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Collinsella aerofaciens as a predictive marker of response to probiotic treatment in non-constipated irritable bowel syndrome.
Gargari, G, Mantegazza, G, Cremon, C, Taverniti, V, Valenza, A, Barbaro, MR, Marasco, G, Duncan, R, Fiore, W, Ferrari, R, et al
Gut microbes. 2024;16(1):2298246
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Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Various therapeutic options for IBS target the underlying pathophysiological aspects of the condition. Unfortunately, no single approach can effectively address this disorder’s diverse manifestations simultaneously. The aim of this study was to identify markers for recognising non-constipated (NC) IBS patients that may show significant clinical improvements upon treatment with the probiotic strain Lacticaseibacillus paracasei DG (LDG). This study is based on a multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial. A total of 63 patients were included in this study who were randomised to receive a probiotic treatment or placebo capsules for 12 weeks. Results showed that the probiotic bacterium LDG can be clinically effective in a subgroup of non-constipated IBS patients characterised by an altered faecal microbiota which resembles that observed in metabolic syndrome-associated pathologic or pre-pathologic conditions. Furthermore, a bacterium reported to contribute to pro-inflammatory immune states, was positively associated with markers of increased endothelial permeability and liver functionality Authors concluded that an analysis of the faecal microbiota focused on particular bacteria could permit the identification of NC-IBS patients who can obtain a significant clinical benefit from the probiotic treatment.
Abstract
Probiotics are exploited for adjuvant treatment in IBS, but reliable guidance for selecting the appropriate probiotic to adopt for different forms of IBS is lacking. We aimed to identify markers for recognizing non-constipated (NC) IBS patients that may show significant clinical improvements upon treatment with the probiotic strain Lacticaseibacillus paracasei DG (LDG). To this purpose, we performed a post-hoc analysis of samples collected during a multicenter, double-blind, parallel-group, placebo-controlled trial in which NC-IBS patients were randomized to receive at least 24 billion CFU LDG or placebo capsules b.i.d. for 12 weeks. The primary clinical endpoint was the composite response based on improved abdominal pain and fecal type. The fecal microbiome and serum markers of intestinal (PV1 and zonulin), liver, and kidney functions were investigated. We found that responders (R) in the probiotic arm (25%) differed from non-responders (NR) based on the abundance of 18 bacterial taxa, including the families Coriobacteriaceae, Dorea spp. and Collinsella aerofaciens, which were overrepresented in R patients. These taxa also distinguished R (but not NR) patients from healthy controls. Probiotic intervention significantly reduced the abundance of these bacteria in R, but not in NR. Analogous results emerged for C. aerofaciens from the analysis of data from a previous trial on IBS with the same probiotic. Finally, C. aerofaciens was positively correlated with the plasmalemmal vesicle associated protein-1 (PV-1) and the markers of liver function. In conclusion, LDG is effective on NC-IBS patients with NC-IBS with a greater abundance of potential pathobionts. Among these, C. aerofaciens has emerged as a potential predictor of probiotic efficacy.
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Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study.
Rondanelli, M, Minisola, S, Barale, M, Barbaro, D, Mansueto, F, Battaglia, S, Bonaccorsi, G, Caliri, S, Cavioni, A, Colangelo, L, et al
Aging clinical and experimental research. 2024;36(1):38
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The occurrence of fractures and osteoporosis are significant concerns in elderly adults, as ageing remains one of the primary risk factors for these conditions. While the incidence of fracture and risk may vary, the incidence of fragility fractures significantly increases with advancing age, particularly after the age of 50 years. This study's aim was to evaluate the adherence, tolerability, and safety of calcium citrate administration in an "outpatient" population in routine clinical practice. This study was a non-interventional, prospective, multicentre study. Two-hundred and sixty-eight individuals (comprised 245 females (91.4%) and 23 males (8.6%)) were enrolled. Results showed a high rate of adherence to calcium citrate supplementation over a one-year period in osteopenic elderly subjects. Additionally, the incidence of adverse reactions was low (3.9%), further emphasizing the tolerability of calcium citrate. Authors concluded that future studies designed to assess the long-term impact of calcium citrate supplementation on hard endpoints, such as bone density, fractures/falls, quality of life measures and adherence are needed.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The occurrence of fractures and osteoporosis are significant concerns in older adults, as ageing remains one of the primary risk factors for this condition.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- This non-interventional, prospective multicentre study suggests a 91% adherence to calcium citrate supplementation over one year in elderly osteopenic patients with generally good (80%) tolerability and 4% reporting gastrointestinal adverse effects.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
A non-interventional, prospective multicentre study was conducted to evaluate the adherence, safety, and tolerability of calcium citrate supplementation in elderly osteopenic subjects.
Method:
A total of 231 Caucasian female (91%) and male (8%) participants with a median age of 70 received 500mg of calcium citrate supplementation daily for one year. Adherence was assessed based on tolerability, compliance, and persistence. Safety evaluations included monitoring of adverse reactions (ARs), physical examinations, and clinical laboratory evaluations.
Results
A total of 222 out of 231 participants (96%) completed the study. Nine subjects did not return for assessments or complete their diaries.
The primary and secondary findings of this study were as follows:
- An average adherence of 91% of oral calcium citrate supplementation was observed which was higher than the reported reference rate of 57% (p = 0.0179).
- Subjects with adherence <80% experienced a higher frequency of adverse events compared to those with adherence >80% (32/77; 42% vs 16/145%, (p = 0.0001).
- Gastrointestinal ARs were the most commonly reported, with constipation comprising 50% of all reported ARs.
- Reductions in systolic (130.7 ± 16.9 mmHg to 127.9 ± 14.5 mmHg) (p = 0.0102) and diastolic blood pressure 79.5 ± 8.7 mmHg to 77.4 ± 8.6 mmHg (baseline to V2) (p = 0.0116) were observed from baseline to the second visit.
- Positive changes were also noted in nutritional status (p = 0.0116), circulatory system disorders (p = 0.0001), and muscles/skeleton disorders (p = 0.0067) from baseline to post-baseline visit.
Conclusion:
This study revealed a 91% adherence to calcium citrate supplementation over one year in older adults with osteopenia, Additionally, the 4% incidents of ARs reported were related to gastrointestinal disorders.
Clinical practice applications:
- The prevalence of osteoporosis rises as individuals age, with approximately 10% of women at 60 years, 20% at 70 years, and 40% at 80 years.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- The safety of calcium supplements remains controversial regarding an increased risk of cardiovascular events. Therefore, it is essential to investigate the safety profile of calcium in these populations.
- This study reported adherence, tolerability, and safety of calcium citrate supplementation in osteopenic elderly patients with 4% of patients reporting gastrointestinal adverse effects.
Considerations for future research:
- This study was conducted on 91% Caucasian females and 8% males with a mean age of 70 years therefore, there is a need to include more male and Asian participants from various age groups in further research.
- Future studies are needed to assess the long-term impact of calcium citrate supplementation on bone density, fractures, and quality of life.
Abstract
BACKGROUND Osteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone health, reducing fracture risk, and supporting overall skeletal strength in this vulnerable population. However, there is conflicting evidence on the safety of calcium supplements in elderly individuals. AIM: The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. METHODS In this non-interventional, prospective, multicenter study, subjects received daily 500 mg calcium citrate supplementation for up to one year. Adherence was calculated based on compliance and persistence. Safety was assessed through adverse reactions (ARs), deaths, and clinical laboratory evaluations. RESULTS A total of 268 Caucasian subjects (91.4% female, mean age 70 ± 4.5 years) participated in the study. Mean adherence to treatment was 76.6 ± 29.5% and half of subjects had an adherence of 91% and ~ 33% of participants achieved complete (100%) adherence. ARs were reported by nine (3.9%) subjects, primarily gastrointestinal disorders, with no serious ARs. The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% (41.6%; 32/77) vs. those with adherence ≥ 80% (11%; 16/145, p < 0.0001). Both systolic and diastolic blood pressure decreased from baseline to follow-up visit (change of -2.8 ± 13.9 mmHg, p = 0.0102 and -2.1 ± 10.4 mmHg, p = 0.0116, respectively). CONCLUSION This study demonstrated favorable adherence to calcium citrate supplementation in elderly osteopenic subjects. The occurrence of ARs, though generally mild, were associated with lower adherence to calcium supplementation.
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Effect of a dietary intervention based on the Mediterranean diet on the quality of life of patients recovered from depression: Analysis of the PREDIDEP randomized trial.
Cabrera-Suárez, BM, Lahortiga-Ramos, F, Sayon-Orea, C, Hernández-Fleta, JL, González-Pinto, A, Molero, P, Vega-Pérez, R, Sánchez-Villegas, A
Experimental gerontology. 2023;175:112149
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Unipolar depression is a prevalent and disabling condition that negatively influences quality of life. Patients with depression are more vulnerable to have a poorer health-related quality of life (HRQoL). The aim of this study was to assess the effect of 2-year intervention with Mediterranean Diet enriched with extra virgin olive oil on HRQoL. This study is a multicentre, randomised, controlled, single-blind trial. The study included 52 men and 144 women aged between 18 and 86 years who had suffered at least one depression episode and who were in a stage of clinical remission. The participants were randomly assigned to the intervention or control group. Results show that a Mediterranean diet–based nutritional intervention enriched with extra virgin olive oil compared with usual care, resulted in a significantly greater increase in HRQoL in recovered depressed patients. This association was greater for the mental dimensions rather than the physical dimensions. Furthermore, this association was also observed for participants aged 60 or more. Authors conclude that since depression is an important condition for its high prevalence, economic cost and personal suffering, it is important to evaluate cost-effective, safe, and inexpensive interventions, such as Mediterranean Diet nutritional interventions.
Abstract
INTRODUCTION There is substantial evidence supporting that improving diet quality leads to improved health-related quality of life (HRQoL). Our major aim was to assess the effectiveness of a Mediterranean diet-based nutritional intervention to improve HRQoL in the context of a secondary prevention trial of depression. Secondarily to assess its effectiveness among adults aged 60 or more years. METHODS The PREDIDEP study is a 2-year multicentre, randomized, single-blinded nutritional trial. At baseline and at 1-year and 2-year follow-up, SF-36 health survey questionnaire was collected to evaluate participants' HRQoL (total and specific range for each of the 8 dimensions: 0 to 100 points). Mixed effect linear models were used to assess changes in HRQoL according to adherence to the Mediterranean diet. The trial was registered at ClinicalTrials.govNCT03081065. RESULTS After 2 years of intervention, the Mediterranean Diet intervention group compared to control group (without nutritional intervention, only usual clinical care) showed an improvement in some dimensions of HRQoL such as Mental Health (7.22; 95 % CI = 2.22-12.22) (between-group difference: 6.79; 95 % CI -0.14-13.73, p = 0.055); Vitality (9.51; 95 % CI = 4.00-15.03) (between-group difference: 9.00; 95 % CI 1.75-16.25, p = 0.020); Mental Summary Component (2.83; 95 % CI = 0.55-5.11) (between-group difference: 1.17; 95 % CI = -1.96-4.30, p = 0.462); and General Health (10.70; 95 % CI = 5.58-15.81) (between-group difference: 6.20; 95 % CI = -0.89-13.28, p = 0.086). Similar results were observed for participants aged 60 or more years. CONCLUSION The intervention based on Mediterranean diet in patients with previous depression seems to be effective in improving HRQoL, especially the mental dimensions. This effect is also observed among participants aged 60 or more years.
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The effects of Bacillus coagulans MTCC 5856 on functional gas and bloating in adults: A randomized, double-blind, placebo-controlled study.
Majeed, M, Nagabhushanam, K, Paulose, S, Arumugam, S, Mundkur, L
Medicine. 2023;102(9):e33109
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The reasons for bloating and feelings of stomach discomfort are not fully understood and it is thought that they may be caused by several factors. Amongst these is the possibility that small intestinal bacterial overgrowth (SIBO) and gut microbiota alterations play a role in the development of bloating. Many therapies exist for the symptomatic relief of bloating, however probiotics may be effective for the relief of bloating due to the role of gut microbiota in its development. This randomised control trial of 66 individuals with abdominal bloating, discomfort, and gas aimed to determine the effectiveness of a gut bacteria strain known as Bacillus coagulans MTCC 5856 on feelings of gas and bloating. The results showed that supplementation with B. coagulans MTCC 5856 for 4 weeks relieved feelings of bloating, burping, and gas. It was concluded that B. coagulans MTCC 5856 supplementation was effective at relieving gas and bloating and may be a safe approach for individuals who experience these symptoms. This study could be used by healthcare professionals to recommend B. coagulans MTCC 5856 as a safe and effective therapy for individuals who suffer from gastrointestinal problems such as gas, bloating and stomach discomfort.
Abstract
BACKGROUND Gut microbiome dysbiosis is a major cause of abdominal gas, bloating, and distension. Bacillus coagulans MTCC 5856 (LactoSpore) is a spore-forming, thermostable, lactic acid-producing probiotic that has numerous health benefits. We evaluated the effect of Lacto Spore on improving the clinical symptoms of functional gas and bloating in healthy adults. METHODS Multicenter, randomized, double-blind, placebo-controlled study at hospitals in southern India. Seventy adults with functional gas and bloating with a gastrointestinal symptom rating scale (GSRS) indigestion score ≥ 5 were randomized to receive B coagulans MTCC 5856 (2 billion spores/day, N = 35) or placebo (N = 35) for 4 weeks. Changes in the GSRS-Indigestion subscale score for gas and bloating and global evaluation of patient's scores from screening to the final visit were the primary outcomes. The secondary outcomes were Bristol stool analysis, brain fog questionnaire, changes in other GSRS subscales, and safety. RESULTS Two participants from each group withdrew from the study and 66 participants (n = 33 in each group) completed the study. The GSRS indigestion scores changed significantly (P < .001) in the probiotic group (8.91-3.06; P < .001) compared to the placebo (9.42-8.43; P = .11). The median global evaluation of patient's scores was significantly better (P < .001) in the probiotic group (3.0-9.0) than in the placebo group (3.0-4.0) at the end of the study. The cumulative GSRS score, excluding the indigestion subscale, decreased from 27.82 to 4.42% (P < .001) in the probiotic group and 29.12 to 19.33% (P < .001) in the placebo group. The Bristol stool type improved to normal in both the groups. No adverse events or significant changes were observed in clinical parameters throughout the trial period. CONCLUSIONS Bacillus coagulans MTCC 5856 may be a potential supplement to reduce gastrointestinal symptoms in adults with abdominal gas and distension.
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Effects of an educational intervention on frailty status, physical function, physical activity, sleep patterns, and nutritional status of older adults with frailty or pre-frailty: the FRAGSALUD study.
Casals, C, Ávila-Cabeza-de-Vaca, L, González-Mariscal, A, Marín-Galindo, A, Costilla, M, Ponce-Gonzalez, JG, Vázquez-Sánchez, MÁ, Corral-Pérez, J
Frontiers in public health. 2023;11:1267666
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Frailty and pre-frailty are associated with an increased risk of premature mortality. Factors involved in the development of frailty include physical activity, sleep and nutrition. The aim of this 6-month randomised controlled trial was to evaluate the effects of an educational programme on frailty, physical function, physical activity, sleep and nutritional status. 166 community-dwelling individuals aged 65 years or over with frailty or pre-frailty were randomised to either receive a health education programme consisting of 4 group sessions in the first month which included guidelines for physical activity, nutrition and cognitive training as well as the promotion of psychological and social wellbeing and 6 follow-up calls over 6 months or their usual healthcare (control). Compared to the control group, the intervention group had significant reductions in frailty score, exhaustion and fatigue score, increase in gait speed and improvements in various physical function tests. The intervention group also showed significant improvements in mini nutritional assessment compared to the control group although this was not associated with significant changes in anthropometric parameters. There was a significant increase in awakenings in the control group whilst this parameter did not change in the intervention group, whilst there were no changes in other sleep parameters. The authors concluded that the simplicity, affordability and effectiveness of the health education programme may contribute to healthy ageing.
Expert Review
Conflicts of interest:
None
Take Home Message:
To improve frailty and physical functioning, a comprehensive programme may be effective, which includes:
- Nutrition
- Physical exercise
- Cognitive training
- Promotion of social and psychological wellbeing.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
- Frailty and pre-frailty increase the risk of premature mortality but are reversible
- The aim of this study was to evaluate the effects of a health education programme on frailty status in frail or pre-frail older persons.
Methods
- Randomised controlled trial
- Participants: 166 community-dwelling individuals aged 65 years or over with frailty or pre-frailty living in Spain were enrolled, 163 completed the study (80 in intervention and 83 in control group)
- Four weekly group sessions which included guidelines for physical activity, nutrition and cognitive training as well as the promotion of psychological and social wellbeing and 6 follow-up calls over 6 months versus usual healthcare (control).
Results
- Baseline demographics: The educational group consisted of more women (p=0.001), had a younger average age (p=0.019), lower height (p=0.001) and a higher average education level (p=0.013) compared to the control group.
Effects on intervention group:
- Reductions in frailty score (p<0.05 vs baseline and change vs change in control group), with 30% of participants in the intervention group no longer being classified as frail or pre-frail in contrast to none in the control group
- Reductions in fatigue and exhaustion score (p<0.05 vs baseline and change vs change in control group)
- Increase in gait speed and improvements in various physical function tests (all p<0.05 vs baseline and change vs change in control group)
- Improvements in mini nutritional assessment (p<0.001 vs baseline and change vs change in control group)
- Improvement in sleep behaviour demonstrated by an increase in awakenings in the control group (p<0.05 vs baseline and change vs change in intervention group) whilst this parameter did not change in the intervention group.
No effects (vs control) on:
- Anthropometric parameters/unintended weight loss
- Other sleep parameters
- Physical activity expenditure and physical activity score
- Hand grip strength.
Conclusion
This affordable and simple health education programme is effective in reducing frailty in elderly and may contribute to healthy ageing.
Clinical practice applications:
- A comprehensive programme, encompassing not only nutrition, but also exercise, cognitive training and a focus on social and psychological wellbeing may be most effective in improving frailty and physical functioning
- Nutrition intervention, alongside other lifestyle interventions, may have benefits for nutritional status in older adults, even if this is not reflected in a change in anthropometric parameters, such as weight.
Considerations for future research:
- Studies with longer-term follow-up would help evaluate whether/for how long the benefits are sustained.
Abstract
INTRODUCTION The prevalence of frailty is increasing worldwide, emphasizing the importance of prioritizing healthy ageing. To address this, cost-effective and minimally supervised interventions are being sought. This study aimed to assess the impact of an educational program on frailty status, physical function, physical activity, sleep patterns, and nutritional status in community-dwelling older adults with at least 1 Fried's frailty criteria. METHODS A 6-month multicentre randomized controlled trial was conducted from March 2022 to February 2023 in 14 health centres located in Cadiz and Malaga, Spain. The educational intervention consisted of 4 group sessions and 6 follow-up phone calls spread over 6 months. The program focused on educating participants about frailty and its impact on health, providing guidelines for physical activity, healthy dietary habits, cognitive training, psychological well-being and social activities. A total of 163 participants, divided into control (n = 80) and educational groups (n = 83) were assessed before and after the intervention. RESULTS The results showed a significant group-time interaction in the physical function evaluated with a large effect on Short Physical Performance Battery score (η2p = 0.179, -0.1 [-1.2-1.0] points for control group vs. 1.0 [0.0-3.0] points for educational group, p < 0.001), and an effect on the 4-meter gait test ((η2p = 0.122, 0.5 [0.1-0.0] s for control group vs. -0.4 [-0.5- -0.3] s for educational group, p < 0.001), and the 5-repetition sit-to-stand test (η2p = 0.136, 1.0 [0.0-1.2] s for control group vs. -4.3 [-7.0- -2.3] for educational group, p < 0.001). Additionally, the use of accelerometers to assess physical activity, inactivity, and sleep patterns revealed a significant small effect in the number of awakenings at night ((η2p = 0.040, 1.1 [-0.5-3.4] awakenings for control group vs. 0.0 [-2.2-0.0] awakenings for educational group, p = 0.009). The findings also highlighted a significant medium effect regarding malnutrition risk, which was assessed using the Mini-Nutritional Assessment score (η2p = 0.088, -0.7 [-2.3-1.5] points for control group vs. 1.5 [-0.5-3.0] points for educational group, p < 0.001). DISCUSSION Thus, the 6-month educational program effectively improved physical function, sleep patterns, and nutritional status compared to usual healthcare attendance in community-dwelling older adults with frailty or pre-frailty. These findings underscore the potential of minimally supervised interventions in promoting a healthy lifestyle in this vulnerable population.
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Association between prealbumin, all-cause mortality, and response to nutrition treatment in patients at nutrition risk: Secondary analysis of a randomized controlled trial.
Bretscher, C, Buergin, M, Gurzeler, G, Kägi-Braun, N, Gressies, C, Tribolet, P, Lobo, DN, Evans, DC, Stanga, Z, Mueller, B, et al
JPEN. Journal of parenteral and enteral nutrition. 2023;47(3):408-419
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Malnutrition amongst the elderly and those who are hospitalised due to multiple illnesses is frequent and increases risk of death. There have however been studies to show that there may be a way of identifying individuals at risk of malnutrition through measurements of biological markers. Prealbumin is a protein made in the liver that has been shown in smaller trials to be a possible biomarker for individuals at risk of malnutrition. This large cohort study of 517 individuals aimed to determine if prealbumin was associated with death and if nutritional support would improve survival. The results showed that individuals who were at risk of malnutrition with low prealbumin levels had almost double the mortality rate after 6 months. However individualised nutritional support did not improve mortality. It was concluded that prealbumin is a prognostic marker for death in nutritionally at-risk patients but does not identify individuals who may respond to nutritional support. This study could be used by healthcare professionals to understand that prealbumin may be helpful in identifying mortality risk amongst individuals at risk of malnutrition but not those who may benefit from personalised nutrition recommendations.
Abstract
BACKGROUND Because of the shorter half-life as compared with albumin, serum prealbumin concentrations have been proposed to be useful nutrition biomarkers for the assessment of patients at nutrition risk. In a post hoc analysis of patients at nutrition risk from a randomized controlled nutrition trial, we tested the hypothesis that (1) prealbumin is associated with higher all-cause 180-day mortality rates and that (2) individualized nutrition support compared with usual-care nutrition more effectively improves survival at 30 days in patients with low prealbumin levels compared with patients with normal prealbumin levels. METHODS We performed a prespecified cohort study in patients included in the pragmatic, Swiss, multicenter randomized controlled EFFORT trial comparing the effects of individualized nutrition support with usual care. We studied low prealbumin concentrations (<0.17 g/L) in a subgroup of 517 patients from one participating center. RESULTS A total of 306 (59.2%) patients (mean age 71.9 years, 53.6% men) had low admission prealbumin levels (<0.17 g/L). There was a significant association between low prealbumin levels and mortality at 180 days (115/306 [37.6%] vs 47/211 [22.3%], fully adjusted hazard ratio [HR]=1.59, 95% CI 1.11-2.28; P = 0.011). Prealbumin levels significantly improved the prognostic value of the Nutritional Risk Screening total score regarding mortality prediction at short- and long-term. The difference in mortality between patients receiving individualized nutrition support and usual-care nutrition was similar for patients with low prealbumin levels compared with patients with normal prealbumin levels (HR=0.90 [95% CI=0.51-1.59] vs HR=0.88 [95% CI=0.35-2.23]) with no evidence for interaction (P = 0.823). CONCLUSION Among medical inpatients at nutrition risk, low admission prealbumin levels correlated with different nutrition markers and higher mortality risk, but patients with low or high prealbumin levels had a similar benefit from nutrition support. Further studies should identify nutrition markers that help further personalize nutrition interventions.
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Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial.
Tantrakul, V, Ingsathit, A, Liamsombut, S, Rattanasiri, S, Kittivoravitkul, P, Imsom-Somboon, N, Lertpongpiroon, S, Jantarasaengaram, S, Somchit, W, Suwansathit, W, et al
Respiratory research. 2023;24(1):171
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Preeclampsia is a leading cause of maternal and foetal morbidity and mortality. Obstructive sleep apnoea (OSA) during pregnancy has been identified as a risk factor for preeclampsia and gestational hypertension. Although continuous positive airway pressure (CPAP) is a standard treatment for OSA in the general population, there is limited data regarding the efficacy and safety of CPAP treatment during pregnancy. The aim of this study was to evaluate the efficacy of CPAP treatment in high-risk pregnancy with mild-to-moderate OSA in reducing BP and hypertensive disorders in pregnancy. This study was a multicentre, open-label, parallel-group randomised controlled trial. Pregnant women attending antenatal care at all collaborating hospitals were recruited. Results showed that CPAP significantly reduced blood pressure (BP), with larger effects on diastolic BP and mean arterial pressure than systolic BP. Furthermore, it reduced the incidence of preeclampsia and hypertensive disorders in pregnancy. Authors conclude that their findings raise the need for early diagnosis and treatment of OSA in high-risk pregnancies.
Abstract
BACKGROUND Obstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA. METHODS A multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5-29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0-16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24-28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence. RESULTS Of 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by - 2.2 mmHg [95% CI (- 3.9, - 0.4), p = 0.014], representing approximately - 0.5 mmHg per hour of CPAP use [95%CI (- 0.89, - 0.10), p = 0.013]. CPAP treatment also altered the blood pressure trajectory by continuously lowering DBP throughout pregnancy with mean differences (95% CI) of - 3.09 (- 5.34, - 0.93), - 3.49 (- 5.67, - 1.31) and - 3.03 (- 5.20, - 0.85) mmHg at GA 18-20, 24-28, and 32-34 weeks, respectively compared to 0-16 weeks. Preeclampsia rate was 13.1% (20/153 participants) in the CPAP and 22.3% (35/157 participants) in the usual-care group with a risk difference (95% CI) of - 9% (- 18%, - 1%, p-value = 0.032) and a number-needed-to-treat (95% CI) of 11 (1, 21). CONCLUSIONS CPAP treatment in women with even mild-to-moderate OSA and high-risk pregnancy demonstrated reductions in both DBP and the incidence of preeclampsia. CPAP treatment also demonstrated a sustained reduction in DBP throughout gestation. Trial registration ClinicalTrial.GovNCT03356106, retrospectively registered November 29, 2017.
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Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Park, SH, Lee, ES, Park, ST, Jeong, SY, Yun, Y, Kim, Y, Jeong, Y, Kang, CH, Choi, HJ
Nutrients. 2023;15(2)
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Bacterial vaginosis (BV) is characterised by the depletion of lactic acid bacteria and overgrowth of certain anaerobic and facultative bacteria leading to an imbalance in the vagina. The high recurrence rate of BV results in repeated exposure to antibiotics and the emergence of drug-resistant bacteria. The aim of this study to evaluate the efficacy of MED-01 [a complex that includes five probiotic strains] on vaginal health and safety This study was a 12-week, randomised, multicentre, double-blind, placebo-controlled clinical trial with two parallel groups receiving either MED-01 or placebo capsules. Results showed that MED-01 intake significantly reduces the Nugent score, a discriminant index of BV, and alleviates symptoms which may appear in BV without any adverse events. Additionally, MED-01 increased the proportion of beneficial Lactobacilli and diminished the harmful BV-causing pathogens. However, there was no significant change in vaginal microbiota. Authors conclude that their findings suggest the possibility of using MED-01 as a new and safe functional probiotic for women with symptoms of BV.
Abstract
Bacterial vaginosis (BV) is the most common disease in women of childbearing age and is caused by the growth of abnormal microbiota in the vagina. Probiotic consumption can be an effective alternative treatment to preserve or improve vaginal health. In the present study, MED-01, a complex of five strains of probiotic candidates isolated from the vagina of Korean women, was used. This study was designed as a 12-week, randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MED-01 on vaginal health. A total of 101 reproductive-aged women with a Nugent score of 4-6 took MED-01 (5.0 × 109 CFU) or a placebo once a day, and 76 participants completed the procedure. MED-01 significantly reduced the Nugent score compared with the placebo. Quantitative PCR analysis confirmed that Lactobacillus plantarum was significantly increased in the vagina, whereas harmful bacteria such as Mobiluncus spp., Gardnerella vaginalis, and Atopobium vaginae were suppressed after 12 weeks of MED-01 ingestion. No adverse events to the test food supplements were observed in the participants. These results confirmed that MED-01 can be used as a probiotic for treating BV, as it improves the vaginal microbiota.
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9.
Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome.
Martoni, CJ, Srivastava, S, Damholt, A, Leyer, GJ
World journal of gastroenterology. 2023;29(28):4451-4465
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Plain language summary
Probiotics are microorganisms that have been shown in previous research to improve symptoms of diarrhoea-predominant irritable bowel syndrome (IBS-D). This randomised control trial of 307 individuals with IBS-D aimed to determine the tolerability and efficacy of varying doses of the microbiota Lactiplantibacillus plantarum. The results showed that the severity of symptoms improved with L. plantarum regardless of whether individuals were given a high or low dose. Improvements were seen as soon as 28 days following supplementation. Abdominal pain severity, duration, bloating, bowel movements, and quality of life were all improved. Individuals in the study largely tolerated the supplement, with only a few occurrences of nausea and vomiting. It was concluded that L. plantarum is effective and safe for improving symptoms associated with IBS-D. This study could be used by healthcare professionals to recommend L. plantarum supplementation to individuals with hard to treat or persistent IBS-D.
Expert Review
Conflicts of interest:
None
Take Home Message:
- This randomised, double-blind, placebo controlled, multi-centre, parallel-arm and dose-ranging study showed that L. plantarum may be a strong candidate for the management of IBS-D symptoms and associated mental health effects.
- L. plantarum may be of particular benefit to individuals who are suffering from stress because of IBS-D.
- L. plantarum is well tolerated and may be of benefit to individuals who have ceased pharmaceutical treatments as a result of side-effects.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
This study aimed to determine the tolerability and efficacy of varying supplemental doses of Lactiplantibacillus plantarum (Lpla33) in adults with irritable bowel syndrome of the diarrhoea predominant subtype (IBS-D).
Methods
This randomised, double blind, placebo-controlled trial recruited 307 females and males aged 18-70 years with IBS-D based upon the Rome IV diagnostic criteria with Bristol Stool Scale stools of type 6 or 7.
Individuals were randomised to receive an eight-week intervention in one of three study groups: Group 1B: Lpla33 at 1 × 109 vs group 10B: 1x1010 colony forming units (CFU) per day vs placebo.
Results
- Improvement was seen in the primary outcome of IBS-D symptom severity (IBS-SSS) with both Lpla33 doses compared to placebo at the end of the trial (P=<0.001).
- Improvements with both doses compared to placebo were seen as quickly as 28 days (P=<0.01).
- At the end of the study the higher dose Lpla33 was more effective at improving IBS-SSS compared to the lower dose (P=<0.05).
- Improvements to IBS remission or mild IBS were seen in 48.1% in group 1B, 72.6% in group 10B and only 11.1% of placebo (P=<0.001).
- Specific improvements were seen in 10B group compared to placebo in abdominal pain severity and duration, abdominal distension, bowel habits, and quality of life (QoL) (P=<0.001).
- Post-hoc analysis showed that supplementation prevented symptom development compared to placebo with 2.9% of group 1B, 2.1% of group 10B and 18.2% of placebo individuals reporting increased symptom severity (P=<0.001).
- QoL and perceived stress were improved with supplementation compared to placebo (P=<0.001 for both), with the higher dose being more beneficial than the lower dose in QoL (P=<0.001).
- Compliance to Lpla33 was comparable to placebo (P=>0.05), with adverse events related to the supplement including nausea and vomiting.
Conclusion
- L. plantarum at doses of 1 × 109 and 1 × 1010 CFU/day is a well-tolerated and efficacious therapy for the improvement of symptoms related to IBS-D, with benefits seen as quickly as 28 days after commencing supplementation.
- Symptoms such as abdominal pain severity and duration, QoL and perceived stress may all be improved.
- Stool normalisation may be seen in certain individuals.
Clinical practice applications:
- L. plantarum supplementation may be of benefit to the management and improvement of symptoms in individuals with IBS-D.
- Improvements may be seen physically and in mental health parameters.
- Metronidazole (400mg/day) was given as a rescue medication for individuals with severe pain and frequent loose stools and should be considered when interpreting results.
Considerations for future research:
- The authors concluded that future research should focus on understanding the mechanisms of action that may be involved.
- Studying the role of diet on the microbial community and metabolite profiles in IBS-D may be of interest.
Abstract
BACKGROUND Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates. AIM: To investigate the clinical efficacy of Lactiplantibacillus plantarum (L. plantarum) Lpla33 (DSM34428) in adults with IBS-D. METHODS This is a randomized, double-blind, placebo-controlled, multi-center, and dose-ranging study. Three hundred and seven adults, 18-70 years of age, with IBS-D, according to Rome IV criteria, were allocated (1:1:1) to receive placebo or L. plantarum Lpla33 at 1 × 109 (1B) or 1 × 1010 (10B) colony-forming units/d over an 8-wk intervention period. The primary outcome was the change in IBS severity scoring system (IBS-SSS) total score after 8 wk, while secondary and exploratory outcomes included abdominal pain severity, IBS related quality of life, stool and microbial profile, and perceived stress. RESULTS IBS-SSS was significantly reduced, after 8 wk, in participants receiving L. plantarum 1B (-128.45 ± 83.30; P < 0.001) and L. plantarum 10B (-156.77 ± 99.06; P < 0.001), compared to placebo (-58.82 ± 74.75). Further, a dose-ranging effect was observed, with a greater absolute reduction in the L. plantarum 10B group (P < 0.05). A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both L. plantarum groups compared to placebo (P < 0.001). Further, 62.5% and 88.4% of participants administered L. plantarum 1B and 10B, respectively, were classified as stool consistency responders based on a reduction in diarrheal stool form, as compared to 26.3% in the placebo group (P < 0.001). In contrast, no significant shifts were observed in microbial diversity. CONCLUSION L. plantarum Lpla33 (DSM34428) is well tolerated and improves IBS symptom severity with a dose-ranging effect and a corresponding normalization of bowel habits in adults with IBS-D.
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10.
Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort-Results of an International Multicenter Randomized Controlled Trial.
Gearry, R, Fukudo, S, Barbara, G, Kuhn-Sherlock, B, Ansell, J, Blatchford, P, Eady, S, Wallace, A, Butts, C, Cremon, C, et al
The American journal of gastroenterology. 2023;118(6):1058-1068
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Functional gastrointestinal disorders (FGID) are now termed disorders of gut-brain interaction. Several studies support the consumption of individual foods to improve laxation and gastrointestinal (GI) comfort. The aim of this study was to investigate the effects of the daily consumption of 2 Zespri green kiwifruits compared with those of 7.5 g of psyllium for 4 weeks on parameters of bowel habit and GI comfort. This study was a prospective randomised, single-blinded, crossover, controlled 16-week trial undertaken in 3 countries. The participants were randomised to consume either of the interventions. Results showed that consumption of 2 Zespri green kiwifruits per day is associated with a clinically significant increase in complete spontaneous bowel movements, improvements in abdominal comfort, straining and stool form, and increases in quality of life. Authors concluded that consumption of 2 green kiwifruits can be safely recommended as an effective treatment for constipation in those with functional GI disorders that will also provide improvements in symptoms of GI comfort.
Abstract
INTRODUCTION Consumption of green kiwifruit is known to relieve constipation. Previous studies have also reported improvements in gastrointestinal (GI) comfort. We investigated the effect of consuming green kiwifruit on GI function and comfort. METHODS Participants included healthy controls (n = 63), patients with functional constipation (FC, n = 60), and patients with constipation-predominant irritable bowel syndrome (IBS-C, n = 61) randomly assigned to consume 2 green kiwifruits or psyllium (7.5 g) per day for 4 weeks, followed by a 4-week washout, and then the other treatment for 4 weeks. The primary outcome was the number of complete spontaneous bowel movements (CSBM) per week. Secondary outcomes included GI comfort which was measured using the GI symptom rating scale, a validated instrument. Data (intent-to-treat) were analyzed as difference from baseline using repeated measures analysis of variance suitable for AB/BA crossover design. RESULTS Consumption of green kiwifruit was associated with a clinically relevant increase of ≥ 1.5 CSBM per week (FC; 1.53, P < 0.0001, IBS-C; 1.73, P = 0.0003) and significantly improved measures of GI comfort (GI symptom rating scale total score) in constipated participants (FC, P < 0.0001; IBS-C, P < 0.0001). No significant adverse events were observed. DISCUSSION This study provides original evidence that the consumption of a fresh whole fruit has demonstrated clinically relevant increases in CSBM and improved measures of GI comfort in constipated populations. Green kiwifruits are a suitable dietary treatment for relief of constipation and associated GI comfort.