An interventional study of Butyrate Formulation and Butyrate + Polyphenol Formulation in Gut Health, sponsored by Supplement Formulators, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Supplement Formulators, Inc. · Not applicable, Interventional, and Treatment
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
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 scheduled remote video calls during the study.
The study subjects will complete assessment tools that include a Rating Scale for Gastrointestinal Symptoms, Quality of Life Questionnaire for Digestion, Visual Analogue Scale of Abdominal Pain, Stool Form Scale, Global Assessment of Improvement Scale-Gastrointestinal and the Short Form-36 Health Survey (SF-36). Laboratory testing will include an assessment of Gut Microbiome, analysis of Short Chain Fatty Acids, a panel for the Gut Barrier and Intestinal Permeability.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
This study's enrollment of 143 is above the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Supplement Formulators, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Butyrate Formulation: Take daily in the morning with 8 oz. (240ml) of water
Dietary Supplement: Butyrate Formulation
Butyrate + Polyphenol Formulation: Take daily in the morning with 8 oz. (240ml) of water
Dietary Supplement: Butyrate + Polyphenol Formulation
Placebo: Take daily in the morning with 8 oz. (240ml) of water
Dietary Supplement: Placebo
Butyrate Formulation capsule: Take daily
Butyrate + Polyphenol Formulation capsule: Take daily
Placebo: Take daily
Assessment of Gut Microbiome
Assessment of the median change in the results of the Gut Microbiome from baseline.
Time frame: 28 days
The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version
Assessment of the median change in the responses on the Gastrointestinal Symptom Rating Scale-IBS from baseline. This scale has questions about how you have been feeling and what it has been like in the past week. The responses to each question range from no discomfort at all to very severe discomfort which would indicate a worse outcome.
Time frame: 28 days
Gut Barrier Panel
Assessment of the median change in the results of the Panel for the Gut Barrier from baseline.
Time frame: 28 days
Short Chain Fatty Acids (SCFA)
Assessment of the median change in the results of the Short Chain Fatty Acid Analysis from baseline.
Time frame: 28 days
Intestinal Permeability Test
Assessment of the median change in the results of the Intestinal Permeability Test from baseline.
Time frame: 28 days
Digestion - Associated Quality of Life Questionnaire (DQLQ)
Assessment of the median change in the responses on the Digestion- Associated Quality of Life Questionnaire (DQLQ) from baseline. The questionnaire has questions related to digestive events and experiences in the last seven days evaluated on a scale from never (0%) to always (100%). The lower score indicates an improved outcome.
Time frame: 28 days
Visual Analogue Scale (VAS) of abdominal pain
Assessment of the median change in the responses on the Visual Analogue Scale questionnaire of abdominal pain from baseline. This scale indicates the response to the intensity of abdominal pain at the time evaluated on a scale from 0 (no pain) to 10 (severe pain). The lower the value indicates an improved outcome.
Time frame: 28 days
Bristol Stool Form Scale (English for United States)
Assessment of the median change in the stool form from baseline. This is related to asking the subject what their stool looked like each time they had a bowel movement for the day. There are 7 various stool types to choose ranging from Type 1 to Type 7. Types 3 or 4 are the preferred types.
Time frame: 28 days
Gastrointestinal- Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Assessment of the median change in the responses on the Gastrointestinal- Global Assessment of Improvement Scale from baseline. This scale indicates the status of the gastrointestinal symptoms over the past 7 days. The responses range from substantially worse to substantially improved which would indicate an improved outcome.
Time frame: 28 days
Short Form-36 Health Survey (SF-36 Health Survey)
Assessment of the median change in the responses to the SF-36 Health Survey from baseline. This is a 36-item questionnaire that covers eight domains including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The scores from each domain can range from 0 to 100. The higher the scores for each domain indicates a better outcome.
Time frame: 28 days
Plan to share: No
Ran from Oct 2023 to primary completion in Dec 2024, 13 months.
Of 101 interventional studies with no phase under Abdominal Pain, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Supplement Formulators, Inc.