Trials / Recruiting
RecruitingNCT07371975
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- Supplement Formulators, Inc. · Industry
- Sex
- All
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.
Detailed description
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals. Participants will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Butyrate + Polyphenol Formulation | Butyrate + Polyphenol Formulation |
| DIETARY_SUPPLEMENT | Placebo | Placebo |
Timeline
- Start date
- 2025-10-16
- Primary completion
- 2026-04-26
- Completion
- 2026-07-30
- First posted
- 2026-01-28
- Last updated
- 2026-01-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07371975. Inclusion in this directory is not an endorsement.