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

Supplement Formulators

Status: Completed

Conditions: Gut Health

Treatments: Dietary Supplement: Butyrate Formulation; Dietary Supplement: Placebo; Dietary Supplement: Butyrate + Polyphenol Formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06419231

CL115

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 3 patient groups, including a placebo group

Butyrate Formulation

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Butyrate Formulation

Butyrate + Polyphenol Formulation

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Butyrate + Polyphenol Formulation

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo