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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 belowSelect...
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:Select...
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
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 moreTrial 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
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
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