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

Launched by SUPPLEMENT FORMULATORS, INC. · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different treatments on gut health: one treatment contains butyrate on its own, and the other combines butyrate with polyphenols, which are natural compounds found in fruits and vegetables. The goal is to see how effective and safe these formulations are for improving gut health, reducing symptoms like bloating, gas, and abdominal pain, and improving the gut's ability to keep substances inside it.

To participate in this trial, you need to be between 21 and 70 years old and experience digestive discomfort at least three times a week. You should be generally healthy and able to fast overnight. However, if you have certain medical conditions, have taken specific medications recently, or have had gastrointestinal issues in the past, you may not be eligible. If you join the study, you can expect to spend about six hours on two separate days completing study-related procedures. This is a great opportunity to potentially improve your gut health while contributing to important research.

Gender

ALL

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

Trial Officials