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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06419231
Other study ID # CL115
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 31, 2023
Est. completion date February 21, 2025

Study information

Verified date May 2024
Source Supplement Formulators, Inc.
Contact Steven Hirsh, RPh, DPM
Phone 954-202-7679
Email shirsh@lifeextension.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 three scheduled remote videoconferencing visits with two scheduled telephone contacts. The study subjects will complete assessment tools that include the Gastrointestinal Symptoms Rating Scale for IBS (GSRS-IBS), Digestion-Associated Quality of Life Questionnaire (DQLQ), Visual Abdominal Scale of Abdominal Pain, Bristol Stool Form (BSFS), Gastrointestinal-Global Assessment of Improvement (Gastrointestinal-GAI) and the Short Form-36 Health Survey (SF-36). Laboratory testing will include Gut Microbiome, Short Chain Fatty Acid Analysis, Gut Barrier Panel and Intestinal Permeability.


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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Butyrate Formulation
Butyrate Formulation capsule:3 capsules daily
Butyrate + Polyphenol Formulation
Butyrate + Polyphenol Formulation capsule: 3 capsules daily
Placebo
Placebo: 3 capsules daily

Locations

Country Name City State
United States Life Extension Clinical Research, Inc. Fort Lauderdale Florida

Sponsors (2)

Lead Sponsor Collaborator
Supplement Formulators, Inc. Compound Solutions Inc.

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Outcome

Type Measure Description Time frame Safety issue
Primary Gut Microbiome Assessment of the median change in the Gut Microbiome from baseline. 28 days
Primary Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS) Assessment of the median change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. 28 days
Secondary Gut Barrier Panel Finger Stick Test Assessment of the median change in the Gut Barrier Panel Finger Stick Test from baseline. 28 days
Secondary Short Chain Fatty Acid Analysis (SCFA) Assessment of the median change in the Short Chain Fatty Acid Analysis from baseline. 28 days
Secondary Intestinal Permeability Test (IP) Assessment of the median change in the Intestinal Permeability Test from baseline. 28 days
Secondary Digestive Quality of Life Questionnaire (DQLQ) Assessment of the median change in the Digestive Quality of Life Questionnaire from baseline. 28 days
Secondary Visual Analogue Scale questionnaire of abdominal pain Assessment of the median change in the Visual Analogue Scale Questionnaire of abdominal pain from baseline. 28 days
Secondary Bristol Stool Form (BSFS) Assessment of the median change in the Bristol Stool Form from baseline. 28 days
Secondary Gastrointestinal- global assessment of improvement scales (Gastrointestinal- GAI) Assessment of the median change in the Gastrointestinal- global assessment of improvement scale from baseline. 28 days
Secondary Short Form-36 Health Survey (SF-36 Health Survey) Assessment of the median change in the SF-36 Health Survey from baseline 28 days
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