NCT06419231

Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms

Detailed description

This is a double-blind, randomized, placebo-controlled, remote design study to evaluate the effects of a Butyrate formulation and Butyrate + Polyphenol formulation on gut health, intestinal permeability and associated symptoms. Participants will be asked to complete laboratory assessments and questionnaires. A total of up to 105 subjects (35 subjects per arm) will be enrolled in a randomly assigned sequence for the 28-day period. There will be scheduled remote video calls during the study. The study subjects will complete assessment tools that include a Rating Scale for Gastrointestinal Symptoms, Quality of Life Questionnaire for Digestion, Visual Analogue Scale of Abdominal Pain, Stool Form Scale, Global Assessment of Improvement Scale-Gastrointestinal and the Short Form-36 Health Survey (SF-36). Laboratory testing will include an assessment of Gut Microbiome, analysis of Short Chain Fatty Acids, a panel for the Gut Barrier and Intestinal Permeability.

Conditions

• Gut Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Butyrate Formulation	Butyrate Formulation capsule: Take daily
DIETARY_SUPPLEMENT	Butyrate + Polyphenol Formulation	Butyrate + Polyphenol Formulation capsule: Take daily
DIETARY_SUPPLEMENT	Placebo	Placebo: Take daily

Timeline

• Start date: 2023-10-31
• Primary completion: 2024-12-23
• Completion: 2025-06-18
• First posted: 2024-05-17
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States