Trial reportJournal of pediatric gastroenterology and nutrition2025
Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial.
Trial report in Journal of pediatric gastroenterology and nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.
What it found
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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.
Butyrate in Children With IBS: Double Blind Placebo Controlled Randomized Clinical Trial
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
Who cites it
3 citing papers in PubMed.
- Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial.Journal of pediatric gastroenterology and nutrition · 2025Trial
- The Gut-Brain Axis in Fetal Alcohol Spectrum Disorder (FASD): Why the Gut Shapes Behavior, Depression, and Self-Injurious Behavior in Children with Prenatal Alcohol Exposure-A Narrative Review with a Proposal for Staged Nutritional and Microbiological Intervention.Journal of clinical medicine · 2026Review
- Reviewing the Peripheral and Central Mechanisms of Visceral Hypersensitivity in Intestinal Disorders.International journal of medical sciences · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
objectiveIrritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders, and treatment involves nonpharmacological and pharmacological therapies, even if there is no optimal therapy. This randomized, placebo-controlled, double-blind trial aimed to evaluate the efficacy of calcium butyrate supplementation in reducing IBS symptoms and to assess its effects on gut microbiota composition and relative metabolic profiles through a multiomics approach.
methodsChildren aged 4-17 years with IBS diagnosed according to the Rome IV criteria were randomized to receive either a formulation based on calcium butyrate (500 mg/day) or placebo for 8 weeks, followed by a 4-week follow-up period. Clinical assessments included the visual analogue scale (VAS) and gastrointestinal symptom rating scale (GSRS). Fecal samples were analyzed via 16S metataxonomics and targeted/untargeted metabolomics. The primary outcome was an ≥50% reduction in the VAS scores. Secondary outcomes included microbiota composition changes and metabolite profile alterations.
resultsFifty-one children were enrolled. Treatment success was significantly higher in the butyrate group (73% vs. 3.8%, p < 0.0001). VAS and GSRS scores were significantly reduced in butyrate-treated patients at the end of treatment and postwashout. Metataxonomic analysis revealed increased short chain fatty acids-producing bacteria, including Lachnospiraceae and Ruminococcus gauvreauii, while pro-inflammatory taxa such as Ruminococcus gnavus decreased. Metabolomics confirmed significant changes in SCFA and VOCs, supporting microbiota modulation. DISCUSSION: Calcium butyrate supplementation effectively reduced IBS symptoms and induced beneficial microbiota and metabolic shifts in pediatric patients. These findings support butyrate as a potential therapy in pediatric IBS, warranting further large-scale investigations to confirm efficacy and optimize dosing strategies. CLINICAL TRIAL IDENTIFICATION NUMBER: Study registered on: https://ClinicalTrials.gov. Number of registration: NCT04566679 Date of registration: 28/09/2020. Date of first enrollment of patients: 01/05/2021.
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Registered trials
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 Socratic graph.