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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419231
• Other study ID #: CL115
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: February 21, 2025

Study information

• Verified date: May 2024
• Source: Supplement Formulators, Inc.
• Contact: Steven Hirsh, RPh, DPM
• Phone: 954-202-7679
• Email: shirsh[@]lifeextension.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Gut Health

Intervention

Dietary Supplement:
• Butyrate Formulation
Butyrate Formulation capsule:3 capsules daily
• Butyrate + Polyphenol Formulation
Butyrate + Polyphenol Formulation capsule: 3 capsules daily
• Placebo
Placebo: 3 capsules daily

Locations

Country	Name	City	State
United States	Life Extension Clinical Research, Inc.	Fort Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Supplement Formulators, Inc.	Compound Solutions Inc.

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

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