Gut Health Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
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
Status | Recruiting |
Enrollment | 105 |
Est. completion date | February 21, 2025 |
Est. primary completion date | January 24, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 70 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Life Extension Clinical Research, Inc. | Fort Lauderdale | Florida |
Lead Sponsor | Collaborator |
---|---|
Supplement Formulators, Inc. | Compound Solutions Inc. |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut Microbiome | Assessment of the median change in the Gut Microbiome from baseline. | 28 days | |
Primary | Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS) | Assessment of the median change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. | 28 days | |
Secondary | Gut Barrier Panel Finger Stick Test | Assessment of the median change in the Gut Barrier Panel Finger Stick Test from baseline. | 28 days | |
Secondary | Short Chain Fatty Acid Analysis (SCFA) | Assessment of the median change in the Short Chain Fatty Acid Analysis from baseline. | 28 days | |
Secondary | Intestinal Permeability Test (IP) | Assessment of the median change in the Intestinal Permeability Test from baseline. | 28 days | |
Secondary | Digestive Quality of Life Questionnaire (DQLQ) | Assessment of the median change in the Digestive Quality of Life Questionnaire from baseline. | 28 days | |
Secondary | Visual Analogue Scale questionnaire of abdominal pain | Assessment of the median change in the Visual Analogue Scale Questionnaire of abdominal pain from baseline. | 28 days | |
Secondary | Bristol Stool Form (BSFS) | Assessment of the median change in the Bristol Stool Form from baseline. | 28 days | |
Secondary | Gastrointestinal- global assessment of improvement scales (Gastrointestinal- GAI) | Assessment of the median change in the Gastrointestinal- global assessment of improvement scale from baseline. | 28 days | |
Secondary | Short Form-36 Health Survey (SF-36 Health Survey) | Assessment of the median change in the SF-36 Health Survey from baseline | 28 days |
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