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

Overview

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

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 three scheduled remote videoconferencing visits with two scheduled telephone contacts. The study subjects will complete assessment tools that include the Gastrointestinal Symptoms Rating Scale for IBS (GSRS-IBS), Digestion-Associated Quality of Life Questionnaire (DQLQ), Visual Abdominal Scale of Abdominal Pain, Bristol Stool Form (BSFS), Gastrointestinal-Global Assessment of Improvement (Gastrointestinal-GAI) and the Short Form-36 Health Survey (SF-36). Laboratory testing will include Gut Microbiome, Short Chain Fatty Acid Analysis, Gut Barrier Panel and Intestinal Permeability.

Eligibility

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 of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea or constipation)
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 (e.g. omeprazole, pantoprazole) within the past 3 months
4. History of oral antibiotic use within the past 3 months
5. Current or previous history of gastrointestinal disease including gallbladder problems, gallstones, biliary obstruction, irritable bowel disease (IBD) or that may interfere with the outcome parameters
6. Current or previous history of gastrointestinal cancer
7. Currently experience or have had a gastrointestinal infection (virus or bacterial) or food poisoning within the past month
8. Currently experience or have had a parasitic infection within the past 3 months
9. Currently experience or have a history of Crohn's disease, colitis, or celiac disease
10. Currently experience or have a history of severe endometriosis
11. History of gastrointestinal surgery which might influence gastrointestinal function except appendectomy or cholecystectomy
12. .History of thyroid disease (except on a stable dose of medication for ≥ 3 months before screening and unlikely to change medication or dose during the study)
13. History of hypertension (except on a stable dose of medication for ≥ 3 months before screening and unlikely to change medication or dose during the study)
14. 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
15. Current or previous history of diabetes
16. History of a major change in dietary habits with the past 1 month
17. History of cancer (including skin cancer) within the past 5 years
18. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose
19. Women who are lactating, pregnant or planning pregnancy within the next two months
20. Women who are currently taking or have taken estrogen and/or progesterone as a method of birth control < 3 months prior to screening or anticipates a change for the duration of the study period
21. Having donated blood or received a blood transfusion within 30 days before screening
22. Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening