Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial.
Fernanda Cristofori, Francesco Maria Calabrese, Ilaria Iacobellis...
https://pubmed.ncbi.nlm.nih.gov/40635319/Actively Recruiting
Led by Supplement Formulators, Inc. · Updated on 2026-01-29
124
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are evaluating the effects of a butyrate and polyphenol formulation on gut health and related symptoms in healthy adults aged 25 to 70 who experience moderate to severe gastrointestinal discomfort. The study aims to understand how this formulation affects the gut microbiome and gastrointestinal symptoms using questionnaires and lab assessments. This is a double-blind, randomized, placebo-controlled study sponsored by Supplement Formulators, Inc. Participants will be randomly assigned to receive either the butyrate plus polyphenol formulation or a placebo. The treatment period lasts 14 days, during which participants take the assigned supplement. The study includes laboratory testing to assess the gut microbiome and various questionnaires to evaluate gastrointestinal symptoms and quality of life. During the study, participants will complete laboratory assessments and several questionnaires, including the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome, digestion-related quality of life surveys, and stool form scales. Researchers will monitor changes in gut microbiome composition and gastrointestinal symptoms over the 14-day period. The study also tracks safety and symptom improvement through standardized scales and quality of life measures.
CONDITIONS
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
S
Steven Hirsh
B
Barbara Martinez
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Supplement Formulators, Inc.
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Butyrate + Polyphenol Supplement | Placebo |
|---|---|---|
| What is it? | Participants took an oral supplement containing butyrate and selected polyphenol extracts intended to support gut microbiome function and digestive comfort. | Participants took placebo capsules that looked identical to the active supplement but contained no butyrate or polyphenols. |
| Role for patients in the study | This was the trial’s active intervention arm, designed to test if butyrate plus polyphenols improve GI-related symptoms and gut health measurements. | The placebo group allowed the study to measure whether any effects seen in the active group exceeded what would occur without active ingredients. |
| Primary use / intended benefit | Intended to improve moderate to severe gastrointestinal symptoms and influence gut microbiome composition in adults without chronic GI disease. | Serves as a no-active-ingredient comparator to evaluate if changes in symptoms or microbiome derive from the supplement rather than placebo effect. |
| How is it given or performed? | Participants took the butyrate and polyphenol capsules orally, following a dosing schedule detailed in the protocol. | Placebo capsules were taken by mouth according to the same schedule as the intervention group. |
| Evidence status and maturity | Butyrate and polyphenol supplements are under investigation for their effects on gastrointestinal symptoms and gut microbiome; results specific to this formulation and population are not yet published. Some studies have shown benefits of butyrate or polyphenols for gut health in other settings, but evidence in adults without GI disease is limited. | Placebo capsules do not contain active ingredients and are not expected to confer health benefits aside from potential placebo effect. |
| Important limitations | It is uncertain whether benefits seen in animal or disease-specific human studies will apply to healthy adults with GI discomfort. Effects may depend on individual microbiome differences, and supplement use should not substitute for medical evaluation of GI symptoms. | The placebo contains no active ingredient, so lack of change cannot determine what would happen with dietary or lifestyle improvement. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive either the butyrate-polyphenol formulation or a placebo to evaluate effects on gut health and associated symptoms.
1 baseline visit and 1 follow-up visit
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/29042289/Supplement Formulators, Inc.
Lead Sponsor