Trial reportDigestive diseases and sciences2015
Melatonin regulation as a possible mechanism for probiotic (VSL#3) in irritable bowel syndrome: a randomized double-blinded placebo study.
Trial report in Digestive diseases and sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05174273 (Understanding the Neurocognitive Effects of Fecal Microbiota Transplantation in Major Depressive Disorder Patients With and Without Irritable Bowel Syndrome), which is not on this map. Cited by 55 papers, 10 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Understanding the Neurocognitive Effects of Fecal Microbiota Transplantation in Major Depressive Disorder Patients With and Without Irritable Bowel Syndrome
Who cites it
55 citing papers in PubMed, 10 syntheses or guidelines pooled it, 104 citations in OpenAlex.
- Pooled it
- The Impact of Dietary Factors on the Sleep of Athletically Trained Populations: A Systematic Review.Nutrients · 2022Pooled it
- Efficacy of Probiotics for Irritable Bowel Syndrome: A Systematic Review and Network Meta-Analysis.Frontiers in cellular and infection microbiology · 2022Pooled it
- Effects of probiotics and paraprobiotics on subjective and objective sleep metrics: a systematic review and meta-analysis.European journal of clinical nutrition · 2020Pooled it
- Pooled it
- Systematic review and meta-analysis: Efficacy of patented probiotic, VSL#3, in irritable bowel syndrome.Neurogastroenterology and motility · 2018Pooled it
- Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria: a meta-analysis.BMC gastroenterology · 2016Pooled it
- Prevalence of sleep disorder in irritable bowel syndrome: A systematic review with meta-analysis.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology AssociationPooled it
- Efficacy and safety of probiotics in irritable bowel syndrome: A systematic review and meta-analysis.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology AssociationPooled it
- Pooled it
- Bifidobacterium longum 1714 improves sleep quality and aspects of well-being in healthy adults: a randomized, double-blind, placebo-controlled clinical trial.Scientific reports · 2024Trial
- Efficacy of double-coated probiotics for irritable bowel syndrome: a randomized double-blind controlled trial.Journal of gastroenterology · 2017Trial
- Article
- Circadian gatekeepers of the gut-brain-immune axis: implications for neuroinflammation and neurodegeneration.Journal of neuroinflammation · 2026Review
- Insomnia: the gut microbiome connection, prospects for probiotic and postbiotic therapies, and future directions.Journal of advanced research · 2026Review
- Beneficial impacts of postbiotic components -- Crosstalk between gut and organs.Current research in food science · 2026Review
- Nutrition Strategies to Promote Sleep in Elite Athletes: A Scoping Review.Sports (Basel, Switzerland) · 2025Review
- Natural Products for the Treatment of Irritable Bowel Syndrome.Gastroenterology & hepatology · 2025Article
- Melatonin-ProducingInternational journal of molecular sciences · 2025Article
- Sleep interventions in elite sport - a systematic review.South African journal of sports medicine · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProbiotics have treatment efficacy in irritable bowel syndrome (IBS), but the exact mechanism remains obscure. One hypothesis is the mediation of melatonin levels, leading to changes in IBS symptoms.
aimThe purpose of this study was to evaluate the effects of a probiotic, VSL#3, on symptoms, psychological and sleep parameters, and pain sensitivity in IBS, and relate these parameters to in vivo melatonin levels.
methodsForty-two IBS patients were randomly assigned to receive VSL#3 or placebo for 6 weeks. Subjects completed bowel and psychological questionnaires, underwent rectal sensitivity testing and saliva melatonin assays.
resultsAbdominal pain duration and distension intensity decreased significantly in the probiotic group, along with an increase in rectal distension pain thresholds. A correlation between increase in pain tolerance and improvement in abdominal pain scores (r = 0.51, p = 0.02) was seen with probiotic. There was an increase in salivary morning melatonin levels in males treated with VSL#3, which correlated (r = 0.61) with improved satisfaction in bowel habits. When grouped based on baseline diurnal melatonin levels, patients with normal diurnal fluctuations showed an increase in morning melatonin levels with VSL#3 treatment, which significantly correlated with improved satisfaction in bowel habits (r = 0.68). They also had reduced symptom severity scores and abdominal pain duration when treated with VSL#3, as well as satisfaction with bowel movements and quality-of-life.
conclusionsVSL#3 improved symptoms and increased rectal pain thresholds. Symptom improvement correlated with a rise in morning melatonin, significant in males and subjects with normal circadian rhythm. This suggests that probiotics may act by influencing melatonin production, hence modulating IBS symptoms, in individuals with a normal circadian rhythm.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.