Gut HealthNCT06419231
Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
A study testing Butyrate Formulation and Butyrate + Polyphenol Formulation in people with Gut Health, run by Supplement Formulators, Inc. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- Butyrate Formulation and Butyrate + Polyphenol Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 18 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory, male or female, 21-70 years of age
- A BMI of 18.5 -34.9
- . Experiences at least three conditions involving gastrointestinal health on a weekly basis
- Are comfortable fasting overnight
- Are able to complete study procedures for up to approximately 6 hours on 2 separate days
- Considered to be generally healthy on the basis of medical history
- Willing to follow study instructions, including compliance with the study procedures and requirements
Who cannot join
- Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
- Currently on a galactose/lactose restricted diet
- Having taken proton pump inhibitors within the past 3 months
- History of oral antibiotic use within the past 3 months
- Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters
- 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
Show all 12Show fewer
- Current or previous history of diabetes
- History of a major change in dietary habits with the past 1 month
- Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose
- Women who are lactating, pregnant or planning pregnancy within the next two months
- Having donated blood or received a blood transfusion within 30 days before screening
- Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, 33304
About this study
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
Read the detailed 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 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.
- Conditions
- Gut Health
- Being tested
- Butyrate Formulation, Butyrate + Polyphenol Formulation, Placebo
- Keywords
- Gastrointestinal discomfort, Abdominal pain, Gas, Bloating, Diarrhea, Constipation, Heartburn, Abdominal discomfort
- Medical subject headings
- Abdominal Pain, Mucopolysaccharidosis IV, Diarrhea, Constipation, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butyrate FormulationDietary supplement
Butyrate Formulation capsule: Take daily
Butyrate + Polyphenol FormulationDietary supplement
Butyrate + Polyphenol Formulation capsule: Take daily
PlaceboDietary supplement
Placebo: Take daily
| Study group | Role | What they receive |
|---|---|---|
| Butyrate Formulation | Active comparator | Butyrate Formulation: Take daily in the morning with 8 oz. (240ml) of water Receives: Dietary Supplement: Butyrate Formulation |
| Butyrate + Polyphenol Formulation | Active comparator | Butyrate + Polyphenol Formulation: Take daily in the morning with 8 oz. (240ml) of water Receives: Dietary Supplement: Butyrate + Polyphenol Formulation |
| Placebo | Placebo comparator | Placebo: Take daily in the morning with 8 oz. (240ml) of water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Gut Microbiome
Assessment of the median change in the results of the Gut Microbiome from baseline.
Measured: 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.
Measured: 28 days
Secondary outcomes (8)
Gut Barrier Panel
Assessment of the median change in the results of the Panel for the Gut Barrier from baseline.
Measured: 28 days
Short Chain Fatty Acids (SCFA)
Assessment of the median change in the results of the Short Chain Fatty Acid Analysis from baseline.
Measured: 28 days
Intestinal Permeability Test
Assessment of the median change in the results of the Intestinal Permeability Test from baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start31 Oct 2023
- Primary completion23 Dec 2024
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Compound Solutions Inc.
- Responsible party
- Sponsor
- Investigators
- Andrew Swick, Ph.D, Principal investigator, Life Extension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419231
- Sponsor's protocol ID
- CL115
- Status last verified
- Jan 2026
- First submitted
- 13 May 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asbaghi O, Nazarian B, Reiner Z, Amirani E, Kolahdooz F, Chamani M, Asemi Z. The effects of grape seed extract on glycemic control, serum lipoproteins, inflammation, and body weight: A systematic review and meta-analysis of randomized controlled trials. Phytother Res. 2020 Feb;34(2):239-253. doi: 10.1002/ptr.6518. Epub 2019 Dec 26.
PubMed 31880030Banasiewicz T, Krokowicz L, Stojcev Z, Kaczmarek BF, Kaczmarek E, Maik J, Marciniak R, Krokowicz P, Walkowiak J, Drews M. Microencapsulated sodium butyrate reduces the frequency of abdominal pain in patients with irritable bowel syndrome. Colorectal Dis. 2013 Feb;15(2):204-9. doi: 10.1111/j.1463-1318.2012.03152.x.
PubMed 22738315Brooker S, Martin S, Pearson A, Bagchi D, Earl J, Gothard L, Hall E, Porter L, Yarnold J. Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration. Radiother Oncol. 2006 Apr;79(1):45-51. doi: 10.1016/j.radonc.2006.02.008. Epub 2006 Mar 20.
PubMed 16546280Canani RB, Costanzo MD, Leone L, Pedata M, Meli R, Calignano A. Potential beneficial effects of butyrate in intestinal and extraintestinal diseases. World J Gastroenterol. 2011 Mar 28;17(12):1519-28. doi: 10.3748/wjg.v17.i12.1519.
PubMed 21472114Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7.
PubMed 30692581Conley BA, Egorin MJ, Tait N, Rosen DM, Sausville EA, Dover G, Fram RJ, Van Echo DA. Phase I study of the orally administered butyrate prodrug, tributyrin, in patients with solid tumors. Clin Cancer Res. 1998 Mar;4(3):629-34.
PubMed 9533530Cory H, Passarelli S, Szeto J, Tamez M, Mattei J. The Role of Polyphenols in Human Health and Food Systems: A Mini-Review. Front Nutr. 2018 Sep 21;5:87. doi: 10.3389/fnut.2018.00087. eCollection 2018.
PubMed 30298133Costa C, Tsatsakis A, Mamoulakis C, Teodoro M, Briguglio G, Caruso E, Tsoukalas D, Margina D, Dardiotis E, Kouretas D, Fenga C. Current evidence on the effect of dietary polyphenols intake on chronic diseases. Food Chem Toxicol. 2017 Dec;110:286-299. doi: 10.1016/j.fct.2017.10.023. Epub 2017 Oct 14.
PubMed 29042289Dallal, G. (2021). www.Randomization.com. http://www.randomization.com
Drugs, O. o. N. (2005). Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Office of the Federal Register National Archives and Record Administration
Edelman MJ, Bauer K, Khanwani S, Tait N, Trepel J, Karp J, Nemieboka N, Chung EJ, Van Echo D. Clinical and pharmacologic study of tributyrin: an oral butyrate prodrug. Cancer Chemother Pharmacol. 2003 May;51(5):439-44. doi: 10.1007/s00280-003-0580-5. Epub 2003 Mar 12.
PubMed 12736763Grosicki, G. (2021). Effects of 3-week Tributyrin Supplementation on the Gut Microbiome: A Pilot Study. Journal of the Academy of Nutrition and Dietetics, 121(9, Supplement), A23. https://doi.org/https://doi.org/10.1016/j.jand.2021.06.051
Hodges, J., Zeng, M., Cao, S., Pokala, A., Rezaei, S., Sasaki, G., Vodovotz, Y., & Bruno, R. (2022). Catechin-Rich Green Tea Extract Reduced Intestinal Inflammation and Fasting Glucose in Metabolic Syndrome and Healthy Adults: A Randomized, Controlled, Crossover Trial. Current Developments in Nutrition, 6(Supplement_1), 981-981. https://doi.org/10.1093/cdn/nzac068.010
Hodgkinson K, El Abbar F, Dobranowski P, Manoogian J, Butcher J, Figeys D, Mack D, Stintzi A. Butyrate's role in human health and the current progress towards its clinical application to treat gastrointestinal disease. Clin Nutr. 2023 Feb;42(2):61-75. doi: 10.1016/j.clnu.2022.10.024. Epub 2022 Nov 2.
PubMed 36502573Istas G, Wood E, Le Sayec M, Rawlings C, Yoon J, Dandavate V, Cera D, Rampelli S, Costabile A, Fromentin E, Rodriguez-Mateos A. Effects of aronia berry (poly)phenols on vascular function and gut microbiota: a double-blind randomized controlled trial in adult men. Am J Clin Nutr. 2019 Aug 1;110(2):316-329. doi: 10.1093/ajcn/nqz075.
PubMed 31152545
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06419231
- Acronym / sponsor ID
- CL115
- Conditions
- Gut Health
- Keywords
- Gastrointestinal discomfort, Abdominal pain, Gas, Bloating, Diarrhea, Constipation, Heartburn, Abdominal discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Compound Solutions Inc.
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Butyrate Formulation | Active comparator | Dietary Supplement: Butyrate FormulationButyrate Formulation: Take daily in the morning with 8 oz. (240ml) of water |
| Butyrate + Polyphenol Formulation | Active comparator | Dietary Supplement: Butyrate + Polyphenol FormulationButyrate + Polyphenol Formulation: Take daily in the morning with 8 oz. (240ml) of water |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo: Take daily in the morning with 8 oz. (240ml) of water |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ambulatory, male or female, 21-70 years of age
- A BMI of 18.5 -34.9
- . Experiences at least three conditions involving gastrointestinal health on a weekly basis
- Are comfortable fasting overnight
- Are able to complete study procedures for up to approximately 6 hours on 2 separate days
Key exclusion criteria (12 listed)
- Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
- Currently on a galactose/lactose restricted diet
- Having taken proton pump inhibitors within the past 3 months
- History of oral antibiotic use within the past 3 months
- Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butyrate FormulationButyrate Formulation capsule: Take daily | Dietary supplement | Butyrate Formulation |
| Butyrate + Polyphenol FormulationButyrate + Polyphenol Formulation capsule: Take daily | Dietary supplement | Butyrate + Polyphenol Formulation |
| PlaceboPlacebo: Take daily | Dietary supplement | Placebo |
Primary outcome
Assessment of Gut Microbiome
Time frame: 28 days
Assessment of the median change in the results of the Gut Microbiome from baseline.
The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version
Time frame: 28 days
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.
8 secondary outcomes
Gut Barrier Panel
Time frame: 28 days
Short Chain Fatty Acids (SCFA)
Time frame: 28 days
Intestinal Permeability Test
Time frame: 28 days
Digestion - Associated Quality of Life Questionnaire (DQLQ)
Time frame: 28 days
Visual Analogue Scale (VAS) of abdominal pain
Time frame: 28 days
Bristol Stool Form Scale (English for United States)
Time frame: 28 days
Gastrointestinal- Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Time frame: 28 days
Short Form-36 Health Survey (SF-36 Health Survey)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 31880030Asbaghi O, Nazarian B, Reiner Z, Amirani E, Kolahdooz F, Chamani M, Asemi Z. The effects of grape seed extract on glycemic control, serum lipoproteins, inflammation, and body weight: A systematic review and meta-analysis of randomized controlled trials. Phytother Res. 2020 Feb;34(2):239-253. doi: 10.1002/ptr.6518. Epub 2019 Dec 26.
- Background: PubMed 22738315Banasiewicz T, Krokowicz L, Stojcev Z, Kaczmarek BF, Kaczmarek E, Maik J, Marciniak R, Krokowicz P, Walkowiak J, Drews M. Microencapsulated sodium butyrate reduces the frequency of abdominal pain in patients with irritable bowel syndrome. Colorectal Dis. 2013 Feb;15(2):204-9. doi: 10.1111/j.1463-1318.2012.03152.x.
- Background: PubMed 16546280Brooker S, Martin S, Pearson A, Bagchi D, Earl J, Gothard L, Hall E, Porter L, Yarnold J. Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration. Radiother Oncol. 2006 Apr;79(1):45-51. doi: 10.1016/j.radonc.2006.02.008. Epub 2006 Mar 20.
- Background: PubMed 21472114Canani RB, Costanzo MD, Leone L, Pedata M, Meli R, Calignano A. Potential beneficial effects of butyrate in intestinal and extraintestinal diseases. World J Gastroenterol. 2011 Mar 28;17(12):1519-28. doi: 10.3748/wjg.v17.i12.1519.
- Background: PubMed 30692581Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7.
- Background: PubMed 9533530Conley BA, Egorin MJ, Tait N, Rosen DM, Sausville EA, Dover G, Fram RJ, Van Echo DA. Phase I study of the orally administered butyrate prodrug, tributyrin, in patients with solid tumors. Clin Cancer Res. 1998 Mar;4(3):629-34.
- Background: PubMed 30298133Cory H, Passarelli S, Szeto J, Tamez M, Mattei J. The Role of Polyphenols in Human Health and Food Systems: A Mini-Review. Front Nutr. 2018 Sep 21;5:87. doi: 10.3389/fnut.2018.00087. eCollection 2018.
- Background: PubMed 29042289Costa C, Tsatsakis A, Mamoulakis C, Teodoro M, Briguglio G, Caruso E, Tsoukalas D, Margina D, Dardiotis E, Kouretas D, Fenga C. Current evidence on the effect of dietary polyphenols intake on chronic diseases. Food Chem Toxicol. 2017 Dec;110:286-299. doi: 10.1016/j.fct.2017.10.023. Epub 2017 Oct 14.
- BackgroundDallal, G. (2021). www.Randomization.com. http://www.randomization.com
- BackgroundDrugs, O. o. N. (2005). Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Office of the Federal Register National Archives and Record Administration
- Background: PubMed 12736763Edelman MJ, Bauer K, Khanwani S, Tait N, Trepel J, Karp J, Nemieboka N, Chung EJ, Van Echo D. Clinical and pharmacologic study of tributyrin: an oral butyrate prodrug. Cancer Chemother Pharmacol. 2003 May;51(5):439-44. doi: 10.1007/s00280-003-0580-5. Epub 2003 Mar 12.
- BackgroundGrosicki, G. (2021). Effects of 3-week Tributyrin Supplementation on the Gut Microbiome: A Pilot Study. Journal of the Academy of Nutrition and Dietetics, 121(9, Supplement), A23. https://doi.org/https://doi.org/10.1016/j.jand.2021.06.051
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Swick, Ph.D principal investigator
Life Extension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butyrate Formulation and Butyrate + Polyphenol Formulation in people with Gut Health, run by Supplement Formulators, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Gut Microbiome (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06419231, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.