Clinical trial NCT06419231: Effectiveness of a Butyrate Formulation and 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gut Health
Keywords: Gastrointestinal discomfort
Abdominal pain
Gas
Bloating
Diarrhea
Constipation
Heartburn
Abdominal discomfort
Lead sponsor: Supplement Formulators, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Compound Solutions Inc.
First posted: 2024-05-17
Enrollment: 105
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 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

Exclusion Criteria:

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

Primary outcomes:
measure: Assessment of Gut Microbiome
timeFrame: 28 days
measure: The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version
timeFrame: 28 days
Secondary outcomes:
measure: Gut Barrier Panel
timeFrame: 28 days
measure: Short Chain Fatty Acids (SCFA)
timeFrame: 28 days
measure: Intestinal Permeability Test
timeFrame: 28 days
measure: Digestion - Associated Quality of Life Questionnaire (DQLQ)
timeFrame: 28 days
measure: Visual Analogue Scale (VAS) of abdominal pain
timeFrame: 28 days
measure: Bristol Stool Form Scale (English for United States)
timeFrame: 28 days
measure: Gastrointestinal- Global Assessment of Improvement Scale (Gastrointestinal-GAI)
timeFrame: 28 days
measure: Short Form-36 Health Survey (SF-36 Health Survey)
timeFrame: 28 days
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Life Extension Clinical Research, Inc.
state: Florida
Study officials:
affiliation: Life Extension
name: Andrew Swick, Ph.D
role: PRINCIPAL_INVESTIGATOR
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