Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Perm… (NCT06419231) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
United States143 participantsStarted 2023-10-31
Plain-language 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
Who can participate
Age range21 Years – 70 Years
SexALL
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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
What they're measuring
1
Assessment of Gut Microbiome
Timeframe: 28 days
2
The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version