RECRUITING

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

Conditions

Gut Health Gastrointestinal discomfort Abdominal pain Gas Bloating Diarrhea Constipation Heartburn Abdominal discomfort

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-10-31

Study Completion:2025-02-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06419231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 a weekly basis 4. Are comfortable fasting overnight 5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days 6. Considered to be generally healthy on the basis of medical history 7. Willing to follow study instructions, including compliance with the study procedures and requirements	1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick 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 or surgery that may interfere with the outcome parameters 6. 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 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 in another clinical research study within 30 days prior to screening

Inclusion Criteria

Exclusion 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 a weekly basis
4. Are comfortable fasting overnight
5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days
6. Considered to be generally healthy on the basis of medical history
7. Willing to follow study instructions, including compliance with the study procedures and requirements

1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
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 or surgery that may interfere with the outcome parameters
6. 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
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 in another clinical research study within 30 days prior to screening

Contacts and Locations

Study Contact

Steven Hirsh, RPh, DPM

CONTACT

954-202-7679

shirsh@lifeextension.com

Principal Investigator

Andrew Swick, Ph.D

PRINCIPAL_INVESTIGATOR

Life Extension

Study Locations (Sites)

Life Extension Clinical Research, Inc.

Fort Lauderdale, Florida, 33304

United States

Collaborators and Investigators

Sponsor: Supplement Formulators, Inc.

Andrew Swick, Ph.D, PRINCIPAL_INVESTIGATOR, Life Extension

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-31

Study Completion Date2025-02-21

Study Record Updates

Study Start Date2023-10-31

Study Completion Date2025-02-21

Terms related to this study

Keywords Provided by Researchers

Gastrointestinal discomfort
Abdominal pain
Gas
Bloating
Diarrhea
Constipation
Heartburn
Abdominal discomfort

Additional Relevant MeSH Terms

Gut Health