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

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.

Inclusion criteria

• 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

Exclusion criteria

• 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