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

NCT06419231 | Completed

• 1 other identifier: CL115
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gut Health

Keywords

Gastrointestinal discomfort; Abdominal pain; Gas; Bloating; Diarrhea; Constipation; Heartburn; Abdominal discomfort

Outcome Measures

Primary Outcomes (2)

• Assessment of Gut Microbiome

  Assessment of the median change in the results of the Gut Microbiome from baseline.

  28 days

• The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version

  Assessment of the median change in the responses on the Gastrointestinal Symptom Rating Scale-IBS from baseline. This scale has questions about how you have been feeling and what it has been like in the past week. The responses to each question range from no discomfort at all to very severe discomfort which would indicate a worse outcome.

  28 days

Secondary Outcomes (8)

• Gut Barrier Panel

  28 days

• Short Chain Fatty Acids (SCFA)

  28 days

• Intestinal Permeability Test

  28 days

• Digestion - Associated Quality of Life Questionnaire (DQLQ)

  28 days

• Visual Analogue Scale (VAS) of abdominal pain

  28 days

Study Arms (3)

Butyrate Formulation

ACTIVE COMPARATOR

Butyrate Formulation: Take daily in the morning with 8 oz. (240ml) of water

Dietary Supplement: Butyrate Formulation

Butyrate + Polyphenol Formulation

ACTIVE COMPARATOR

Butyrate + Polyphenol Formulation: Take daily in the morning with 8 oz. (240ml) of water

Dietary Supplement: Butyrate + Polyphenol Formulation

Placebo

PLACEBO COMPARATOR

Placebo: Take daily in the morning with 8 oz. (240ml) of water

Dietary Supplement: Placebo

Interventions

Butyrate Formulation DIETARY_SUPPLEMENT

Butyrate Formulation capsule: Take daily

Butyrate Formulation

Butyrate + Polyphenol Formulation DIETARY_SUPPLEMENT

Butyrate + Polyphenol Formulation capsule: Take daily

Butyrate + Polyphenol Formulation

Placebo DIETARY_SUPPLEMENT

Placebo: Take daily

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead
• Compound Solutions Inc.: collaborator

Study Sites (1)

Life Extension Clinical Research, Inc.

Fort Lauderdale, Florida, 33304, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Abdominal Pain; Mucopolysaccharidosis IV; Diarrhea; Constipation; Heartburn

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Andrew Swick, Ph.D

  Life Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: October 31, 2023
• Primary Completion: December 23, 2024
• Study Completion: June 18, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)