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

Completed · Not applicable · Has a placebo group

Conditions studied: Gut Health

In brief

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

Key facts

Study ID

NCT06419231

Run by

Supplement Formulators, Inc.

People needed

143

Starts

2023-10-31

Expected to finish

2025-06-18

Last updated by the study team

2026-01-13

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ambulatory, male or female, 21-70 years of age
• A BMI of 18.5 -34.9
• . Experiences at least three conditions involving gastrointestinal health on a weekly basis
• Are comfortable fasting overnight
• Are able to complete study procedures for up to approximately 6 hours on 2 separate days
• Considered to be generally healthy on the basis of medical history
• Willing to follow study instructions, including compliance with the study procedures and requirements

You may not qualify if…

• Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
• Currently on a galactose/lactose restricted diet
• Having taken proton pump inhibitors within the past 3 months
• History of oral antibiotic use within the past 3 months
• Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters
• A medical or surgical event requiring hospitalization, outpatient visits or emergency room visits within the past 5 years or in the judgment of the Study Investigator /Sub-I would preclude participation in the study
• Current or previous history of diabetes
• History of a major change in dietary habits with the past 1 month
• Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose
• Women who are lactating, pregnant or planning pregnancy within the next two months
• Having donated blood or received a blood transfusion within 30 days before screening
• Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening

Where it is running

• Life Extension Clinical Research, Inc. — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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