A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms

ConditionGut Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorSupplement Formulators, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Male or female, age 25-70 years

Body mass index 18.5-34.9 kg/m2

A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may be included at the discretion of the PI/Sub-I

Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)

Disqualifiers

Currently participating in another clinical research study

Pregnant, planning pregnancy, or breastfeeding

Unable to swallow capsules, tablets, or softgels

Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.

Trial design

Treatments tested in this trial

  • Butyrate + Polyphenol Formulation
  • Placebo

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators