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

Last updated: November 26, 2024
Sponsor: Supplement Formulators, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Butyrate + Polyphenol Formulation

Placebo

Butyrate Formulation

Clinical Study ID

NCT06419231
CL115
  • Ages 21-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ambulatory, male or female, 21-70 years of age

  2. A BMI of 18.5 -34.9

  3. . Experiences at least three conditions involving gastrointestinal health on aweekly basis

  4. Are comfortable fasting overnight

  5. Are able to complete study procedures for up to approximately 6 hours on 2 separatedays

  6. Considered to be generally healthy on the basis of medical history

  7. Willing to follow study instructions, including compliance with the study proceduresand requirements

Exclusion

Exclusion Criteria:

  1. Unable to provide a urine specimen, stool specimen or blood sample from a fingerstick

  2. Currently on a galactose/lactose restricted diet

  3. Having taken proton pump inhibitors within the past 3 months

  4. History of oral antibiotic use within the past 3 months

  5. Current or previous history of gastrointestinal disease, cancer, infection orsurgery that may interfere with the outcome parameters

  6. A medical or surgical event requiring hospitalization, outpatient visits oremergency room visits within the past 5 years or in the judgment of the StudyInvestigator /Sub-I would preclude participation in the study

  7. Current or previous history of diabetes

  8. History of a major change in dietary habits with the past 1 month

  9. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol,xylitol, lactulose or lactose

  10. Women who are lactating, pregnant or planning pregnancy within the next two months

  11. Having donated blood or received a blood transfusion within 30 days before screening

  12. Currently participating in another clinical research study or participated inanother clinical research study within 30 days prior to screening

Study Design

Total Participants: 105
Treatment Group(s): 3
Primary Treatment: Butyrate + Polyphenol Formulation
Phase:
Study Start date:
October 31, 2023
Estimated Completion Date:
February 21, 2025

Study 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.

Connect with a study center

  • Life Extension Clinical Research, Inc.

    Fort Lauderdale, Florida 33304
    United States

    Active - Recruiting

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