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Short-Chain Fatty Acid

Butyrate and Polyphenols for Gut Health

N/A

Recruiting

Led By Andrew Swick, Ph.D

Research Sponsored by Supplement Formulators, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ambulatory, male or female, 21-70 years of age

Be older than 18 years old

Must not have

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

Unable to provide a urine specimen, stool specimen, or blood sample from a finger stick

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Summary

"This trial is looking at how effective and safe a Butyrate formulation and a Butyrate + Polyphenol formulation are for improving gut health, permeability, and related symptoms."

Who is the study for?

This trial is for individuals experiencing gut health issues. Participants should be interested in testing the effects of two different supplement formulations on their gut health and related symptoms.

What is being tested?

The study is examining how effective a Butyrate formulation alone, or combined with Polyphenols, is compared to a placebo in improving gut health and reducing permeability issues.

What are the potential side effects?

Potential side effects may include digestive discomfort such as bloating, gas, or changes in bowel movements due to the introduction of new supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 70 years old and can walk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used hormone-based birth control recently or plan to change it during the study.

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I cannot provide urine, stool, or blood samples.

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I have taken antibiotics by mouth in the last 3 months.

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I have had a parasitic infection recently or have one now.

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I have had a stomach bug or food poisoning in the last month.

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I have or had Crohn's, colitis, or celiac disease.

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I have severe endometriosis or have had it in the past.

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I have or had diabetes.

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I am not pregnant, breastfeeding, or planning to become pregnant soon.

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I have or had gastrointestinal cancer.

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I have not had any type of cancer, including skin cancer, in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS)

Gut Microbiome

Secondary outcome measures

Bristol Stool Form (BSFS)

Digestive Quality of Life Questionnaire (DQLQ)

Gastrointestinal- global assessment of improvement scales (Gastrointestinal- GAI)

+5 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Butyrate FormulationActive Control1 Intervention

Butyrate Formulation: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water

Group II: Butyrate + Polyphenol FormulationActive Control1 Intervention

Butyrate + Polyphenol Formulation: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water

Group III: PlaceboPlacebo Group1 Intervention

Placebo: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Compound Solutions Inc.UNKNOWN

4 Previous Clinical Trials

140 Total Patients Enrolled

Supplement Formulators, Inc.Lead Sponsor

13 Previous Clinical Trials

467 Total Patients Enrolled

Andrew Swick, Ph.DPrincipal InvestigatorLife Extension

5 Previous Clinical Trials

110 Total Patients Enrolled

~30 spots leftby Jan 2025

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