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Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial.
Tierney, BT, Versalovic, J, Fasano, A, Petrosino, JF, Chumpitazi, BP, Mayer, EA, Boetes, J, Smits, G, Parkar, SG, Voreades, N, et al
Pediatric research. 2023;93(7):2005-2013
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The composition of the human gut microbiome has been identified as playing a role in regulating bowel movements in children. This includes functional constipation, which is characterised by infrequent bowel movements and associated phenotypes such as stool consistency, pain when defecating and bloating. The aim of this study was to determine the impact of a nine-strain (eight species) synbiotic (a prebiotic and defined microbial consortium) formulation (with the prebiotic comprising mixed-chain length oligosaccharides) on ameliorating constipation. This study was a multicentre, randomised, double-blind, and placebo-controlled with two parallel arms. Ninety-one healthy male/female subjects were recruited and randomly assigned to one of the two arms; treatment or placebo group. Results showed that: - compared to placebo, synbiotic use increased weekly bowel movements (WBMs) in constipated children. - there was an increased abundance of the administered probiotic species (bifidobacteria) in the treatment arm. - baseline microbial richness demonstrated potential as a predictive biomarker for response to intervention. Authors conclude that a synbiotic formulation may increase weekly WBMs in children who have low-frequency WBMs.
Abstract
BACKGROUND Oral microbial therapy has been studied as an intervention for a range of gastrointestinal disorders. Though research suggests that microbial exposure may affect the gastrointestinal system, motility, and host immunity in a pediatric population, data have been inconsistent, with most prior studies being in neither a randomized nor placebo-controlled setting. The aim of this randomized, placebo-controlled study was to evaluate the efficacy of a synbiotic on increasing weekly bowel movements (WBMs) in constipated children. METHODS Sixty-four children (3-17 years of age) were randomized to receive a synbiotic (n = 33) comprising mixed-chain length oligosaccharides and nine microbial strains, or placebo (n = 31) for 84 days. Stool microbiota was analyzed on samples collected at baseline and completion. The primary outcome was a change from baseline of WBMs in the treatment group compared to placebo. RESULTS Treatment increased (p < 0.05) the number of WBMs in children with low baseline WBMs, despite broadly distinctive baseline microbiome signatures. Sequencing revealed that low baseline microbial richness in the treatment group significantly anticipated improvements in constipation (p = 0.00074). CONCLUSIONS These findings suggest the potential for (i) multi-species-synbiotic interventions to improve digestive health in a pediatric population and (ii) bioinformatics-based methods to predict response to microbial interventions in children. IMPACT Synbiotic microbial treatment improved the number of spontaneous weekly bowel movements in children compared to placebo. Intervention induced an increased abundance of bifidobacteria in children, compared to placebo. All administered probiotic species were enriched in the gut microbiome of the intervention group compared to placebo. Baseline microbial richness demonstrated potential as a predictive biomarker for response to intervention.
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Efficacy of a Synbiotic Containing Lactobacillus paracasei DKGF1 and Opuntia humifusa in Elderly Patients with Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.
Oh, JH, Jang, YS, Kang, D, Kim, HS, Kim, EJ, Park, SY, Kim, CH, Min, YW, Chang, DK
Gut and liver. 2023;17(1):100-107
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Irritable bowel syndrome (IBS) affects 1 in 10 people globally and is a common health problem for the elderly. Recent studies have shown that changes in the gut microbiome may play an important part in IBS and there is evidence that using pre and pro biotics have positive effects on IBS. The aim of this randomized, double-blind, placebo-controlled trial was to determine the effects of a new synbiotic formulation (L. paracasei DKGF1 and prebiotics extracted from O. humifusa) on GI symptoms in elderly patients with IBS. 67 participants were randomly divided into 2 groups. For 4 weeks one group took the synbiotic and the other group took a placebo. Symptoms were recorded via questionnaires. The consumption of the synbiotic combination was associated with overall relief of IBS symptoms in elderly patients. In particular, abdominal pain and psychological well-being noticeably improved. In conclusion this synbiotic is effective and safe to use in elderly patients with global IBS symptoms.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The management of IBS in elderly people is more complicated than in younger populations.
- Synbiotic formulations containing both probiotics and prebiotics have reported gastrointestinal health benefits.
- This randomized controlled trial indicated that the synbiotic containing L. paracasei DKGF1 and Optuntia humifusa extracts might be effective and safe for treating IBS symptoms in elderly patients.
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:
This study involved a randomized, double-blind, placebo-controlled trial to investigate the impact of a synbiotic combination, comprising of L. paracasei DKGF1 and prebiotics extracted from Optuntia humifusa, on Irritable Bowel Syndrome (IBS) in elderly patients.
Method
Sixty-seven IBS patients (mean age: 64 years) were randomly assigned to either a synbiotic group (n=33) or a placebo group (n=34) for a 4-week intervention. The synbiotic group received a daily sachet containing one billion colony-forming units of L. paracasei DKGF1, 0.2g of O. humifusa extract and 1.59 grams of maltodextrin, while the placebo group received an identical sachet containing only maltodextrin.
During the study period
- Participants recorded the degree of symptom improvement using a Subject Global Assessment (SGA) scale.
- IBS symptoms, abdominal pain, gas, bloating, and psychological well-being were recorded using a Visual Analogue Scale (VAS).
- Stool form and consistency were assessed using a Bristol Stool Chart (BSC).
Results
The primary findings from the study were as follows:
- There was significant improvement in IBS symptoms as measured by the SGA score, in the synbiotic group versus the placebo group (+50.5% vs +23.5%, p=0.017). The synbiotic group consistently demonstrated improved response rates.
The secondary findings were as follows:
- Participants also reported an improvement in psychological well-being in the synbiotic group (from 1.3 to 1.0) compared to the placebo group (from 3.0 to 2.0) (p=0.003).
- Responders reported a significant improvement in stool form and consistency in the synbiotic group (+85.7%) compared to the placebo group (+22.2%) (p=0.04).
- Among the patients with IBS constipation, patients in the synbiotic group reported a positive response compared to the placebo group (0% and +100%, p=0.029).
- . However, there was no significant improvement among the patients with IBS diarrhoea in the synbiotic group compared to the placebo group (+33.3% and +66.6%,, p=0.52).
Conclusion:
This randomized, double-blind, placebo-controlled trial, reported that the synbiotic combination of L. paracasei DKGF1 and Optuntia humifusa, may be associated with the relief of IBS symptoms in elderly patients, particularly in terms of abdominal pain and psychological well-being.
Clinical practice applications:
- The human microbiota undergoes changes in diversity and variation with age, emphasising the importance of understanding age-specific interventions.
- Managing IBS in the elderly is challenging, and synbiotics, containing both probiotics and prebiotics, have reported gastrointestinal health benefits.
- Most clinical trials have excluded elderly patients, and there has been uncertainty about whether synbiotic use is safe for the elderly.
- This study focused exclusively on elderly patients with IBS, indicating the potential safety and effective use of a synbiotic containing L. paracasei DKGF1 and Optuntia humifusa in improving IBS symptoms.
Considerations for future research:
- Only elderly patients were included in this study, therefore further investigation is needed to explore the effects of synbiotics on participants of different age groups.
- Microbial analysis was not done in this study. It would be useful to include this in future research to gain more insight into the microbiome’s diversity in elderly patients with IBS.
- The study did not quantify food intake or variety which might have impacted the results, therefore future research needs to consider the impact diet has on the microbiome and IBS.
- Since patient reports are subjective, future research should consider involving researchers during patient-reported assessments to enhance the accuracy and reliability of the data.
Abstract
BACKGROUND/AIMS: There is increasing evidence that supplementation with pre- and probiotics appears to have positive effects on irritable bowel syndrome (IBS). The aim of this study was to determine the effects of a new synbiotic formulation on gastrointestinal symptoms in elderly patients with IBS. METHODS Sixty-seven IBS patients aged ≥60 years were randomly assigned to either a placebo group (n=34) or a synbiotic group (n=33). During a 4-week intervention, subjects used a placebo or a synbiotic containing Lactobacillus paracasei DKGF1 and extracts of Opuntia humifusa once a day. Patients were evaluated with the subject global assessment, visual analog scale, and Bristol stool chart. The primary outcome was the overall responder rate and the secondary outcome was the responder rates for abdominal symptom reduction at week 4. RESULTS Overall, responder rates were significantly higher in the synbiotic group (51.5%) than in the placebo group (23.5%) (p=0.017). Abdominal pain (58.8% vs 81.8%) and psychological well-being (26.4% vs 60.6%) were noticeably improved in the synbiotic group (p=0.038 and p=0.004, respectively). However, there were no significant differences in gas and bloating symptoms (p=0.88 and p=0.88, respectively). In patients with constipation-dominant and diarrhea-dominant IBS (n=16), the synbiotic significantly improved abdominal pain and defecation symptoms (responder rates for the placebo vs the synbiotic: 22.2% vs 85.7%, p=0.04). There were no adverse events in either group. CONCLUSIONS The results indicate that this new synbiotic supplement can potentially relieve abdominal symptoms in elderly IBS patients.
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Interaction of cervical microbiome with epigenome of epithelial cells: Significance of inflammation to primary healthcare.
Holubekova, V, Kolkova, Z, Kasubova, I, Samec, M, Mazurakova, A, Koklesova, L, Kubatka, P, Rokos, T, Kozubik, E, Biringer, K, et al
Biomolecular concepts. 2022;13(1):61-80
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A female health is one medical area of the framework strategies in predictive, preventive, and personalized (3P) medicine. Cervical cancer is preventable and successfully treatable at early stages that makes the disease as an ideal candidate applicable in the context of 3P medicine. The aim of this study was to examine the interaction of the cervical microbiome with epithelial cells in relation to inflammation, and to assess direct evidence of epigenetic changes related to the cervical microbiome. This study is a systematic review of publications in the field of cervical cancer research. This review shows that: - cervical cancer screening in future integration of precision cancer prevention regimes should match an individual’s risk of cancer in context with genomic and environmental factors. - identification of microbiome population might be one of the key aspects of precision medicine in the future. Microbial composition may early identify the potential risk of precancerous lesion formation or permanent bacterial vaginosis. - the composition of the microbiome can be influenced by dietary composition, which will also affect the epigenetic background of the microbiome. However, food forms the microbiome through epigenetic mechanisms, and it is thus necessary to clarify how cancer risk is increased due to food-related microbially produced metabolites. - an examination of the metabolites during inflammation of the cervical epithelium and bacterial vaginosis may improve the precise identification of inflammatory-induced biomarkers that could aid in the precision medicine in prediction of the risk of cervical dysplasia development. - cancer-associated inflammation pathways can be influenced by phytochemicals with anti-inflammatory effects on immune cells, suppression of proinflammatory transcription factors, cytokines, and chemokines. The biological balance between uncontrolled chronic inflammation and controlled inflammation is essential for cancer prevention, prediction, and prognostication. Authors conclude that their review highlighted the pivotal contribution of cervical microbiome, epigenetic changes, and inflammation to the formation of cervical intraepithelial lesion and progression to cervical cancer.
Abstract
One pillar of the predictive, preventive, and personalized medicine framework strategies is the female health. The evaluation of women's lifestyle and dietary habits in context with genetic and modifiable risk factors may reflect the prevention of cervical cancer before the occurrence of clinical symptoms and prediction of cervical lesion behavior. The main aim of this review is to analyze publications in the field of precision medicine that allow the use of research knowledge of cervical microbiome, epigenetic modifications, and inflammation in potential application in clinical practice. Personalized approach in evaluating patient's risk of future development of cervical abnormality should consider the biomarkers of the local microenvironment characterized by the microbial composition, epigenetic pattern of cervical epithelium, and presence of chronic inflammation. Novel sequencing techniques enable a more detailed characterization of actual state in cervical epithelium. Better understanding of all changes in multiomics level enables a better assessment of disease prognosis and selects the eligible targeted therapy in personalized medicine. Restoring of healthy vaginal microflora and reversing the outbreak of cervical abnormality can be also achieved by dietary habits as well as uptake of prebiotics, probiotics, synbiotics, microbial transplantation, and others.
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The role of diet and probiotics in prevention and treatment of bacterial vaginosis and vulvovaginal candidiasis in adolescent girls and non-pregnant women.
Mizgier, M, Jarzabek-Bielecka, G, Mruczyk, K, Kedzia, W
Ginekologia polska. 2020;91(7):412-416
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In adolescent girls and non-pregnant women, vaginitis, including fungal infections, is a common problem. Vaginitis clinically manifests as abnormal vaginal discharge, irritation, itching, burning and discomfort, and is especially prevalent with a decrease in immunity. The normal bacterial flora of the vagina and cervix protect against the development of pathogenic strains, while abnormal flora tend to be the most common starting point for the development of infections. The aim of this study was to determine the role of proper diet and probiotics and prebiotics use in relation to therapy and prophylaxis of vulvovaginal candidiasis (VVC) and bacterial vaginosis (BV) in non-pregnant women and girls. This review shows that: - An unbalanced diet can be a risk factor for BV. Women tend to be more exposed to BV if they have poor micronutrient status, including vitamins A, E, D, C and beta carotene — indicating a lower fruit and vegetable intake. - Many studies proved that regulated use of probiotics, administered both orally and vaginally, are effective in the prevention and treatment of vaginal infections such as BV and VVC. - To create a positive environment for probiotics, it is important to provide prebiotics that support the development of probiotic strains. Authors conclude that gynaecologists, obstetricians, general practitioners and dieticians should share their findings, and raise awareness among the general population as to the importance of optimal nutrition. Probiotics and prebiotics could be considered to prevent infections of the genital tract, reduce associated disease, and maintain reproductive health.
Abstract
The article raises important issues regarding the use of diet and probiotics in prevention and treatment of vaginitis. Vaginitis is defined as any condition with symptoms of abnormal vaginal discharge. The most common causes of vaginitis are vulvovaginal candidiasis (VVC), trichomoniasis and bacterial vaginosis (BV). Vaginitis has been linked to itching, burning, pain, discharge, irritation and also adverse reproductive and obstetric health outcomes. Moreover, microorganisms that build vaginal flora in the state of bacterial vaginosis are a source of cervicitis and endometritis (often in subclinical forms) and pelvic inflammatory disease (PID) The proper diet and probiotics consumption may influence the composition of the gut microbiota, improve gut integrity, and have an impact on maintaining and recovering the normal vaginal microbiota. Future studies and reviews investigating the role of diet and probiotics in changes to gut and vaginal microbiome need to focus on deciphering the mechanismus of host bacteria interaction in vulvovaginal health.
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Functional interactions between the gut microbiota and host metabolism.
Tremaroli, V, Bäckhed, F
Nature. 2012;489(7415):242-9
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This literature review aims to discuss evidence for the role of the gut microbiota in metabolism and possible links to obesity. Obesity and caloric intake can influence the microbiota, but whether the reverse is true in humans remains unclear. Much of the mechanisms have been determined in rodents, determining similar pathways in humans is difficult. The interplay of diet, host and gut microbiota may cause increased gut permeability (leaky gut) that could lead to an increase in inflammation that may cause obesity, fatty liver disease and insulin resistance. It is increasingly accepted that gut microbiota can contribute to diseases such as obesity, diabetes and cardiovascular disease, but exactly how and by how much remains unclear. Evidence for treating the microbiota to help with these metabolic diseases, either by pre- or probiotic supplementation, is building. However, double-blind, placebo-controlled studies are required to determine effects. The influence of the gut microbiota is a promising area, but one that needs further research.
Abstract
The link between the microbes in the human gut and the development of obesity, cardiovascular disease and metabolic syndromes, such as type 2 diabetes, is becoming clearer. However, because of the complexity of the microbial community, the functional connections are less well understood. Studies in both mice and humans are helping to show what effect the gut microbiota has on host metabolism by improving energy yield from food and modulating dietary or the host-derived compounds that alter host metabolic pathways. Through increased knowledge of the mechanisms involved in the interactions between the microbiota and its host, we will be in a better position to develop treatments for metabolic disease.