0
selected
-
1.
Efficacy of diet restriction with or without probiotic for treatment of patients with IBS-D: Phase I-II clinical trial.
Zhao, XS, Shi, LJ, Ning, BL, Zhao, ZM, Li, XX, Zhu, MH, Zhang, YB, Fu, J
Immunity, inflammation and disease. 2023;11(5):e857
-
-
-
-
Free full text
Plain language summary
Irritable bowel syndrome (IBS) is a functional intestinal disorder that can significantly affect quality of life. IBS patients suffer from intermittent abdominal pain/ discomfort, altered bowel habits, and abdominal bloating/distension. The aim of this study was to assess the effects of dietary restriction and probiotic use on IBS‐D patients. This study was a 2 × 2 factorial design, single‐centre, randomised trial. Phase 1 was a 12‐week dietary intervention, with 214 participants randomised to an IgG positive restricted diet (IgG res diet) or a control diet (cold/spicy/fried restricted). In Phase 2, 167 participants were randomised into either an IgG res diet + placebo or an IgG res diet + probiotic for 12 weeks. Symptom Severity Scale (IBS‐D‐SSS) and IgG titer were assessed at the beginning and the end of the study. Results showed that both diets reduced IBS‐D symptom severity scores and decreased immunoglobulin (IgG) antibody titer, although the IgG res diet had a greater impact. IBS symptom scores decreased with the addition of a Bifidobacterium probiotic along with dietary exclusion, however, IgG titers did not change with the probiotic compared to placebo. Authors concluded that diet restriction with appropriate and effective probiotics, provides greater symptom reductions for patients with IBS-D.
Expert Review
Conflicts of interest:
None
Take Home Message:
For individuals with IBDS-D:
- Establish IgG intolerances to foods and ensure an elimination diet remains nutritionally balanced
- Consider combining elimination diet with a Bifidobacterium supplement.
Evidence Category:
-
X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
-
B: Systematic reviews including RCTs of limited number
-
C: Non-randomized trials, observational studies, narrative reviews
-
D: Case-reports, evidence-based clinical findings
-
E: Opinion piece, other
Summary Review:
Introduction
Irritable bowel syndrome (IBS) is a common functional intestinal disorder, affecting 5-20% of the population and diet is likely a major factor in its development as well as in its management. The aim of this study was to compare 3 dietary interventions and the use of a probiotic supplement in patients with IBS-diarrhoea dominant (IBS-D).
Methods
The study was conducted in 2 phases. The first was a 12-week 2 × 2 factorial design, randomised dietary intervention and included 224 patients (214 completed) with IBS-D. The diets were an Eastern/Chinese restriction diet, avoiding cold/raw, spicy and fried foods (CSF), the second avoided common allergens as determined by an IgG test (IgG diet, 14 foods tested), the third a combination of the two, whilst the control group continued their usual (Eastern/Chinese) diet.
The second phase was a 12-week randomised, double-blind, placebo-controlled trial comparing the CSF + IgG diet plus placebo with the CSF + IgG diet plus a 2 billion Bifidobacterium adolescentis supplement; this part included 202 patients of whom 169 completed the study.
The primary outcomes under observation were a reduction in IBS-D symptom severity Score (IBS-D-SSS) and IgG antibody titre (TigG).
Results
Phase 1: The IBS-D-SSS improved in all four groups from baseline (p<0.001), with the intervention groups improving significantly more than the control group (p<0.001). There was no statistically significant difference between the IgG and the IgG + CSF groups, although the authors considered there to be a synergistic effect. Statistically significant (p<0.001) reductions in TIgG were seen in all interventions, but not the control group.
Part 2: Significant (p<0.001) improvements in IBS-D-SSS were seen with both placebo and Bifidobacterium, although this was greater in the probiotic group (p<0.001). Improvements in TIgG were seen in both groups (p<0.001), with no difference between groups.
Conclusion
The authors concluded that the best intervention for patients with IBD-D is an IgG food elimination diet together with a Bifidobacterium probiotic supplement.
Clinical practice applications:
- Consider an elimination diet based on IgG testing for clients with IBS-D
- Consider combining elimination diet with a Bifidobacterium supplement. The dose used in this study was 4x 0.5 billion capsules of Bifidobacterium adolescentis
- Eliminating cold/raw, spicy and fried food could be an alternative to IgG elimination if the latter is not suitable for the client.
Considerations for future research:
- 45% and 35% of screened patients, respectively in the 2 phases of the study, were IgG negative. Screening for more potential food intolerances may extend the suitability of the approach to more patients
- Only a single strain probiotic was tested. Further research could evaluate other or combinations of Bifidobacteria strains in combination with an IgG elimination diet
- The mechanism(s) by which probiotics may affect symptoms of IBS-D are unknown. Adding stool microbiome analyses may shed further light on the effect of the intervention on the composition and function of the microbiome.
Abstract
BACKGROUND AND AIM Diet is a major contributor to irritable bowel syndrome (IBS) and is also a powerful tool for treatment of IBS. This study compared two diets and explored the effectiveness of the diets when combined with a probiotic for treatment of IBS-D patients. METHODS Phase I, patients were randomized into groups; control, cold/spicy/fried restricted diet (CSF res diet), IgG positive restricted diet (IgG res diet), and a combination both diets (CSF + IgG res diet). Phase II, patients were randomized into IgG res diet + placebo and IgG res diet + probiotic. Both interventions were 12 weeks in duration. Symptom Severity Scale (IBS-D-SSS) and IgG titer were assessed at the beginning and the end of the study. RESULTS Totals of 214 and 167 patients completed the two parts of the study, respectively. After intervention, IBS-D-SSS and TIgG grade were significantly improved compared to baseline, with results similar to the control group. In general, there were decreases in IBS-D-SSS and TIgG grade that were significantly different among the groups. There were exceptions; no differences were observed for IBS-D-SSS between the IgG res diet and CSF + IgG res diet, or TIgG grade between the CSF res diet, IgG res diet, and CSF + IgG res diet. However, the CSF res diet and IgG res diet had a synergistic effect that decreased IBS-D-SSS and TIgG titer, with a greater contribution by the IgG res diet. Therefore, we evaluated the IgG res diet with either placebo or probiotic and found that IBS-D-SSS and TIgG grade decreased from baseline. There was a significant decrease in IBS-D-SSS with the probiotic but TIgG grade was not significantly different between the IgG diet + placebo and IgG diet + probiotic diet. CONCLUSIONS Both the CSF res diet and IgG res diet improved IBS symptoms and demonstrated synergy, although the IgG res diet had a greater contribution. Further, when intolerant foods cannot be eliminated from a diet, avoiding uncooked, cold, spicy, fried, and alcoholic foods is a superior choice. The IgG res diet combined with Bifidobacteria was the best dietary choice and may function though a non-IgG pathway.
-
2.
PRO-DEMET Randomized Controlled Trial on Probiotics in Depression-Pilot Study Results.
Gawlik-Kotelnicka, O, Margulska, A, Skowrońska, A, Strzelecki, D
Nutrients. 2023;15(6)
-
-
-
Free full text
Plain language summary
Depression often coexists with metabolic abnormalities, and metabolic syndrome (MetS) is diagnosed in 30% of depressed subjects. Importantly, both obesity and MetS have been found to be independently associated with depressive symptoms and inflammation. The aim of this study was to investigate the effect of probiotics in the treatment of depressive disorders with possible comorbid MetS and its components. This study was an internal feasibility study based on the main randomised study - a single-centre, parallel-group, prospective, randomised, double-blind, placebo-controlled pilot trial. Adult patients (≥18 years) with depressive disorders were randomly assigned (1:1) into either the placebo or probiotic group. Results showed a positive association between probiotics supplementation and psychometric parameters together with the metabolic profile, serum inflammation markers, and biomarkers of metabolic-associated fatty liver disease in patients with depressive disorders. Authors conclude that the findings of their study would be suitable for determining the potential clinical use of probiotics and assessing certain key factors such as potential biomarkers of response.
Abstract
There is a pressing need to identify new treatment options for depression and its comorbidities. Depression often coexists with metabolic complications, and the two may share a pathophysiological overlap, including inflammation and microbiota changes. Microbiota interventions (e.g., probiotics) may represent a safe and easy-to-use treatment option as an adjunctive therapy in patients only partially responsive to pharmacologic treatment. (1) Objective: The paper presents the results of a feasibility and pilot study. The study is an internal part of a randomized controlled trail (RCT) of the effect of probiotic supplementation on psychometric, anthropometric, metabolic, and inflammatory parameters in adult patients with depressive disorders depending on the presence of metabolic syndrome. (2) Methods: The trial has a four-arm, parallel-group, prospective, randomized, double-blind, controlled design. Sixty participants received a probiotic preparation containing Lactobacillus helveticus Rosell®-52 and Bifidobacterium longum Rosell®-175 over 60 days. The feasibility of the study design was assessed, as well as the rates of recruitment, eligibility, consent, and study completion. The following were assessed: depressive, anxiety and stress symptoms, quality of life, blood pressure, body mass index and waist circumference, complete blood count with differential, serum levels of C-reactive protein, high-density lipoprotein cholesterol, triglycerides, fasting glucose, some secondary markers of inflammation and metabolic health, as well as noninvasive biomarkers of liver fibrosis (APRI and FIB-4). (3) Results: The study was found to be generally feasible. The eligibility rate was 52% of recruited participants with 80% completing the study protocol. No differences in sociodemographic or anthropometric factors or basic laboratory findings were found between the placebo and probiotic group at the start of the intervention period. Importantly, the proportion of recruited participants fulfilling the criteria of metabolic syndrome was too low. (4) Conclusions: Whilst the whole study protocol was feasible, some different timepoint procedures require modification. The major weakness of the recruitment methods was that the percentage of metabolic arms participants was insufficient. Overall, the full RCT design on probiotics in depression with vs. without metabolic syndrome was shown to be feasible with little modification.
-
3.
Effect of Lactobacillus casei on lipid metabolism and intestinal microflora in patients with alcoholic liver injury.
Li, X, Liu, Y, Guo, X, Ma, Y, Zhang, H, Liang, H
European journal of clinical nutrition. 2021;75(8):1227-1236
-
-
-
Free full text
-
Plain language summary
Alcoholic liver disease (ALD) is a series of liver diseases caused by long-term heavy drinking. Lipid metabolism disorder often occurs in people with alcoholic liver injury. Treatment is mainly a combination of alcohol abstinence, improving nutrition, treating the liver injury, and preventing or reversing the progress of liver fibrosis or promoting liver regeneration. The aim of this study was to investigate the effect of Lactobacillus casei on lipid metabolism and intestinal microflora in patients with alcoholic liver injury. This study was a randomised, double-blind, placebo-controlled trial. A total of 181 ALD patients were recruited and randomly assigned to one of the three groups; low-dose group, high-dose group and positive control group (+ there was another group of 20 healthy people which served as normal control group). Results showed disorder of lipid metabolism, intestinal flora imbalance and inflammation in patients with alcoholic liver injury. Furthermore, after supplementation of Lactobacillus casei, there was a significant increase in the amount of Lactobacillus and Bifidobacterium. Authors conclude that Lactobacillus casei supplementation can improve lipid metabolism and regulate intestinal flora disorders in patients with alcoholic liver injury.
Abstract
BACKGROUND The present study aims to investigate the effect of Lactobacillus casei on lipid metabolism and intestinal microflora in patients with alcoholic liver injury. METHODS In a double-blind randomized controlled trial, 158 recruited alcoholic liver injury patients were randomized to three treatments for 60 days: low-dose group (LP, n = 58, 100 ml of Lactobacillus casei strain Shirota (LcS)), high-dose group (HP, n = 54, 200 ml of LcS), and positive control group (PC, n = 46, 100 ml of special drinks without active Lactobacillus casei). Another group of 20 healthy people was served as normal control group (NC). RESULTS The serum levels of TG and LDLC in the HP group were significantly decreased by 26.56% and 23.83%, respectively than those in the PC group (P < 0.05). After supplementation of Lactobacillus casei, there was a significant increase in the amount of Lactobacillus and Bifidobacterium when compared with the PC group (P < 0.05). CONCLUSIONS Supplementation of Lactobacillus casei can improve lipid metabolism and regulate intestinal flora disorders in patients with alcoholic liver injury.
-
4.
Multi-strain probiotics (Hexbio) containing MCP BCMC strains improved constipation and gut motility in Parkinson's disease: A randomised controlled trial.
Ibrahim, A, Ali, RAR, Manaf, MRA, Ahmad, N, Tajurruddin, FW, Qin, WZ, Desa, SHM, Ibrahim, NM
PloS one. 2020;15(12):e0244680
-
-
-
Free full text
Plain language summary
Constipation is one of the commonest non-motor symptoms in Parkinson’s disease (PD). Recently, gut dysbiosis with alterations in faecal microbial composition was associated with the pathogenesis of PD and constipation. The aim of this study was to analyse the efficacy of a multi-strain probiotic combined with a prebiotic fibre (fructo-oligosaccharide) compared to placebo, on constipation symptoms and intestinal motility, in PD patients with constipation. This study is an eight-week investigator-initiated, double-blind, randomised, placebo-controlled single centre clinical trial involving 55 idiopathic PD patients. Patients were randomly assigned to one of the two treatment groups. Results showed that: - the consumption of a multi-strain probiotic (Hexbio) over 8 weeks, significantly improved bowel opening frequency and gut transit time in PD patients with constipation. - PD patients who consumed probiotics experienced a significantly higher mean weekly bowel movement compared to the placebo group. - patients who received probiotics reported increased weekly bowel opening frequency. - the percentage of patients who remained constipated was also significantly lower in the probiotic group (22.7%) compared to 57.7% in the placebo group. Authors conclude that Hexbio containing MCP BCMC strains was safe and effective in improving bowel opening frequency and gastrointestinal motility in PD patients with constipation.
Abstract
OBJECTIVE We determined the effectiveness of a multi-strain probiotic (Hexbio®) containing microbial cell preparation MCP®BCMC® on constipation symptoms and gut motility in PD patients with constipation. METHODS PD patients with constipation (ROME III criteria) were randomized to receive a multi-strain probiotic (Lactobacillus sp and Bifidobacterium sp at 30 X 109 CFU) with fructo-oligosaccaride or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes were changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary outcomes were gut transit time (GTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS). RESULTS Of 55 recruited, 48 patients completed the study: 22 received probiotic and 26 received placebo. At 8 weeks, there was a significantly higher mean weekly BOF in the probiotic group compared to placebo [SD 4.18 (1.44) vs SD 2.81(1.06); (mean difference 1.37, 95% CI 0.68, 2.07, uncorrected p<0.001)]. Patients in the probiotic group reported five times higher odds (odds ratio = 5.48, 95% CI 1.57, 19.12, uncorrected p = 0.008) for having higher BOF (< 3 to 3-5 to >5 times/week) compared to the placebo group. The GTT in the probiotic group [77.32 (SD55.35) hours] reduced significantly compared to placebo [113.54 (SD 61.54) hours]; mean difference -36.22, 95% CI -68.90, -3.54, uncorrected p = 0.030). The mean change in GTT was 58.04 (SD59.04) hour vs 20.73 (SD60.48) hours respectively (mean difference 37.32, 95% CI 4.00, 70.63, uncorrected p = 0.028). No between-groups differences were observed in the NMSS, PDQ39-SI, MDS-UPDRS II and MDS-UPDRS III scores. Four patients in the probiotics group experienced mild reversible side effects. CONCLUSION This study showed that consumption of a multi-strain probiotic (Hexbio®) over 8 weeks improved bowel opening frequency and whole gut transit time in PD patients with constipation.
-
5.
Effect of Lactobacillus plantarum TWK10 on Exercise Physiological Adaptation, Performance, and Body Composition in Healthy Humans.
Huang, WC, Lee, MC, Lee, CC, Ng, KS, Hsu, YJ, Tsai, TY, Young, SL, Lin, JS, Huang, CC
Nutrients. 2019;11(11)
-
-
-
Free full text
Plain language summary
Probiotics are widely used for health promotion. This study specifically looks at one strain of Lactobacillus plantarum TWK10 and its effects on physiology and body composition in 54 healthy participants (50/50 men and women), aged 20-30 years, none of which were professional athletes. The double-blind placebo-controlled experiment divided the participants into groups of placebo, low dose probiotics and high dose probiotics to determine the effects of probiotics on exercise performance over a 6 week period. During this time the participants were required to carry out a series of treadmill exercises and biometric exams including monitoring heart rate, oxygen consumption, body mass, and fatigue parameters measured in blood work (serum lactate, ammonia, glucose, creatine kinase, aspartate transaminase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and uric acid) for physiological adaption. The results showed that the probiotics elevated exercise performance and improved fatigue in a dose-dependent manner. They observed that muscle mass increased and fat mass decreased in the treatment groups compared to the placebo. As such they conclude that Lactobacillus plantarum TWK10 has beneficial physiological effects to improve aerobic performance.
Abstract
Probiotics have been rapidly developed for health promotion, but clinical validation of the effects on exercise physiology has been limited. In a previous study, Lactobacillus plantarum TWK10 (TWK10), isolated from Taiwanese pickled cabbage as a probiotic, was demonstrated to improve exercise performance in an animal model. Thus, in the current study, we attempted to further validate the physiological function and benefits through clinical trials for the purpose of translational research. The study was designed as a double-blind placebo-controlled experiment. A total of 54 healthy participants (27 men and 27 women) aged 20-30 years without professional athletic training were enrolled and randomly allocated to the placebo, low (3 × 1010 colony forming units (CFU)), and high dose (9 × 1010 CFU) TWK10 administration groups (n = 18 per group, with equal sexes). The functional and physiological assessments were conducted by exhaustive treadmill exercise measurements (85% VO2max), and related biochemical indices were measured before and after six weeks of administration. Fatigue-associated indices, including lactic acid, blood ammonia, blood glucose, and creatinine kinase, were continuously monitored during 30 min of exercise and a 90 min rest period using fixed intensity exercise challenges (60% VO2max) to understand the physiological adaptation. The systemic inflammation and body compositions were also acquired and analyzed during the experimental process. The results showed that TWK10 significantly elevated the exercise performance in a dose-dependent manner and improved the fatigue-associated features correlated with better physiological adaptation. The change in body composition shifted in the healthy direction for TWK10 administration groups, especially for the high TWK10 dose group, which showed that body fat significantly decreased and muscle mass significantly increased. Taken together, our results suggest that TWK10 has the potential to be an ergogenic aid to improve aerobic endurance performance via physiological adaptation effects.
-
6.
Effect of probiotic supplements in women with gestational diabetes mellitus on inflammation and oxidative stress biomarkers: a randomized clinical trial.
Hajifaraji, M, Jahanjou, F, Abbasalizadeh, F, Aghamohammadzadeh, N, Abbasi, MM, Dolatkhah, N
Asia Pacific journal of clinical nutrition. 2018;27(3):581-591
-
-
-
Free full text
Plain language summary
Gestational diabetes mellitus (GDM) is a common metabolic condition in pregnancy in which the pregnant woman has high serum glucose levels during gestation. It is characterised by maternal insulin resistance and is associated with inflammation throughout gestation. The aim of this study was to measure the effect of a probiotic supplement capsule containing four bacterial strains in comparison with a placebo on inflammatory and oxidative stress biomarkers among women with newly diagnosed GDM. This study is a randomised controlled trial. The patients were randomly allocated to receive either a probiotic supplement or a placebo capsule once a day for eight weeks. Results show that both inflammatory and oxidative stress biomarkers improved after the use of the probiotic supplement when compared to the placebo. The differences for two of the three inflammatory biomarkers (C-reactive protein and tumour necrosis factor-α) were statistically significant. The levels for the biomarker interlukin-6 did not change significantly between groups. Authors conclude that a probiotic supplement (containing L.acidophilus LA-5, Bifidobacterium BB-12, S.thermophilus STY-31 and L.delbrueckii bulgaricus LBY-2) improves several inflammatory and oxidative stress biomarkers in women with GDM.
Abstract
BACKGROUND AND OBJECTIVES Very little is known about the use of probiotics among pregnant women with gestational diabetes mellitus (GDM) especially its effect on oxidative stress and inflammatory indices. The aim of present study was to measure the effect of a probiotic supplement capsule on inflammation and oxidative stress biomarkers in women with newly-diagnosed GDM. METHODS AND STUDY DESIGN 64 pregnant women with GDM were enrolled in a double-blind placebo controlled randomized clinical trial in the spring and summer of 2014. They were randomly assigned to receive either a probiotic containing four bacterial strains of Lactobacillus acidophilus LA-5, Bifidobacterium BB-12, Streptococcus Thermophilus STY-31 and Lactobacillus delbrueckii bulgaricus LBY-27 or placebo capsule for 8 consecutive weeks. Blood samples were taken pre- and post-treatment and serum indices of inflammation and oxidative stress were assayed. The measured mean response scales were then analyzed using mixed effects model. All statistical analysis was performed using Statistical Package for Social Sciences (SPSS) software (version 16). RESULTS Serum high-sensitivity C-reactive protein and tumor necrosis factor-α levels improved in the probiotic group to a statistically significant level over the placebo group. Serum interleukin-6 levels decreased in both groups after intervention; however, neither within group nor between group differences interleukin-6 serum levels was statistically significant. Malondialdehyde, glutathione reductase and erythrocyte glutathione peroxidase levels improved significantly with the use of probiotics when compared with the placebo. CONCLUSIONS The probiotic supplement containing L.acidophilus LA- 5, Bifidobacterium BB- 12, S.thermophilus STY-31 and L.delbrueckii bulgaricus LBY-2 appears to improve several inflammation and oxidative stress biomarkers in women with GDM.