Gut HealthNCT07371975
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
A study testing Butyrate + Polyphenol Formulation in people with Gut Health, run by Supplement Formulators, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- Butyrate + Polyphenol Formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to 7 Jul 2026
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 25-70 years
- Body mass index 18.5-34.9 kg/m2
- A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may be included at the discretion of the PI/Sub-I
- Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
- Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
- Weight stable for the past six months (±6 lbs.)
Show all 9Show fewer
- Willing and able to give written informed consent
- Ability to communicate and read in English
- Ability to comply with study requirements
Who cannot join
- Currently participating in another clinical research study
- Pregnant, planning pregnancy, or breastfeeding
- Unable to swallow capsules, tablets, or softgels
- Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.
- Typically goes longer than 3 days without a bowel movement
- Current diagnosis of cardiovascular disease, history of an abnormal electrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except for non-melanoma skin cancer) within the past 5 years
Show all 28Show fewer
- Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.
- Planning to undergo a major medical procedure or surgical event within the next 30 days
- Currently being treated for any infectious disease
- Currently consuming more than 6 standard alcoholic drinks per week for women and 10 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
- Smoking or use of nicotine products daily within 30 days prior to screening
- Using substances of abuse or recreational drugs/substances, including tetrahydrocannabinol (THC), within the past 14 days
- History of intolerance or allergic reaction to product ingredients, including butyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamon extract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)
- Having donated blood or received a blood/plasma transfusion within 30 days before baseline
- History of a major change in dietary habits within the past 1 month
- Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation
- Currently taking any laxatives on a daily basis
- Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.
- On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
- History of oral or IV antibiotic use within the past 3 months prior to Baseline
- Not willing to refrain from taking any over-the-counter medications or supplements for gastrointestinal concerns or discomfort (except if on a stable dose for > 3 months before Screening and unlikely to change) unless in the judgment of the PI/Sub-I
- Current or previous history of medically diagnosed and treated gastrointestinal disease, including gallbladder problems, gallstones, biliary obstruction, inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiac disease, or gastrointestinal cancer
- Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
- Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month
- Currently experiencing or previously having a parasitic infection within the past 3 months
- Currently experiencing or having a history of severe endometriosis
- History of gastrointestinal surgery, which might influence gastrointestinal function
- History or presence of a clinically significant diagnosis or circumstance that, in the judgment of the Study Investigator/Sub-I, would interfere with the interpretation of the study results and preclude participation in the study -
Trial locations and contacts
1 site in 1 country.
United States1 site
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, 33304
About this study
The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.
Read the detailed description
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals.
Participants will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.
- Conditions
- Gut Health
- Being tested
- Butyrate + Polyphenol Formulation, Placebo
- Keywords
- Gastrointestinal discomfort, Abdominal pain, Gas, Bloating, Diarrhea, Constipation
- Medical subject headings
- Abdominal Pain, Mucopolysaccharidosis IV, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butyrate + Polyphenol FormulationDietary supplement
Butyrate + Polyphenol Formulation
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Butyrate + Polyphenol Formulation | Active comparator | Butyrate + Polyphenol Formulation Receives: Dietary Supplement: Butyrate + Polyphenol Formulation |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
Change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. The responses to the questions range from no discomfort at all to very severe discomfort which would indicate a worse outcome
Measured: 14 days
Gut Microbiome Stool Test
Change in the Gut Microbiome (strain level, functional metrics, taxonomy abundance and composition) from baseline
Measured: 14 days
Secondary outcomes (5)
Digestion-Associated Quality of Life Questionnaire (DQLQ)
Change in the Digestion-Associated Quality of Life Questionnaire (DQLQ) from baseline. The lower score indicates an improved outcome.
Measured: 14 days
Visual Analogue Scale (VAS) of abdominal pain
Change in the Visual Analogue Scale (VAS) of abdominal pain from baseline. The lower the value indicates an improved outcome.
Measured: 14 days
Bristol Stool Form Scale (BSFS)
Change in the stool form from baseline. There are 7 various stool types to choose ranging from Type 1 to Type 7. Types 3 or 4 are the preferred types.
Measured: 14 days
Gastrointestinal -Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Change in the Gastrointestinal-Global Assessment of Improvement Scale (Gastrointestinal-GAI) from baseline. The responses range from substantially worse to substantially improved would indicate an improved outcome.
Measured: 14 days
World Health Organization Quality of Life (WHOQOL-BREF)
Change in the World Health Organization Quality of Life (WHOQOL-BREF) from baseline. The higher score indicates a better perceived quality of life for each domain.(physical health, psychological health, social relationship, environment)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start16 Oct 2025
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Swick, PhD, Principal investigator, Life Extension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371975
- Sponsor's protocol ID
- CL116
- Status last verified
- Aug 2026
- First submitted
- 19 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Administration, D. o. H. a. H. S. U. S. F. a. D. (2005). Guidance for industry : estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers : pharmacology and toxicology. Center for Drug Evaluation and Research.
Cleophas 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 29042289Cristofori F, Calabrese FM, Iacobellis I, Santamaria M, Celano G, Ferrocino I, Di Sabato E, Pergola R, Dargenio VN, Paulucci L, De Angelis M, Francavilla R. Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial. J Pediatr Gastroenterol Nutr. 2025 Sep;81(3):551-561. doi: 10.1002/jpn3.70154. Epub 2025 Jul 9.
PubMed 40635319Grosicki, 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), A23.
Hodges, J. Z., 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, 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 36502573Huang Q, Braffett BH, Simmens SJ, Young HA, Ogden CL. Dietary Polyphenol Intake in US Adults and 10-Year Trends: 2007-2016. J Acad Nutr Diet. 2020 Nov;120(11):1821-1833. doi: 10.1016/j.jand.2020.06.016. Epub 2020 Aug 15.
PubMed 32807722Kapolou, A. K. H. R., N; Koutelidakis, A. (2021). Association of Mean Daily Polyphenols Intake with Mediterranean Diet Adherence and Anthropometric Indices in Healthy Greek Adults: A Retrospective Study. Applied Sciences, 11(10). https://doi.org/10.3390/app11104664
Ljotsson B, Jones M, Talley NJ, Kjellstrom L, Agreus L, Andreasson A. Discriminant and convergent validity of the GSRS-IBS symptom severity measure for irritable bowel syndrome: A population study. United European Gastroenterol J. 2020 Apr;8(3):284-292. doi: 10.1177/2050640619900577. Epub 2020 Jan 14.
PubMed 32213021Ma G., C., Y. (2020). Polyphenol supplementation benefits human health via gut microbiota: A systematic review via meta-analysis. . Journal of Functional Foods, 66(103829).
Park SY, Kim YD, Kim MS, Kim KT, Kim JY. Cinnamon (Cinnamomum cassia) water extract improves diarrhea symptoms by changing the gut environment: a randomized controlled trial. Food Funct. 2023 Feb 6;14(3):1520-1529. doi: 10.1039/d2fo01835g.
PubMed 36655542Pietrzak A, Banasiuk M, Szczepanik M, Borys-Iwanicka A, Pytrus T, Walkowiak J, Banaszkiewicz A. Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized Placebo-Controlled Multicenter Trial. Nutrients. 2022 Aug 11;14(16):3283. doi: 10.3390/nu14163283.
PubMed 36014789
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
- ClinicalTrials.gov ID
- NCT07371975
- Acronym / sponsor ID
- CL116
- Conditions
- Gut Health
- Keywords
- Gastrointestinal discomfort, Abdominal pain, Gas, Bloating, Diarrhea, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 28 Jan 2026 (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 the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.
Detailed description
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals.
Participants will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butyrate + Polyphenol Formulation | Active comparator | Dietary Supplement: Butyrate + Polyphenol FormulationButyrate + Polyphenol Formulation |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age 25-70 years
- Body mass index 18.5-34.9 kg/m2
- A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may be included at the discretion of the PI/Sub-I
- Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
- Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
Key exclusion criteria (28 listed)
- Currently participating in another clinical research study
- Pregnant, planning pregnancy, or breastfeeding
- Unable to swallow capsules, tablets, or softgels
- Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.
- Typically goes longer than 3 days without a bowel movement
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 + Polyphenol FormulationButyrate + Polyphenol Formulation | Dietary supplement | Butyrate + Polyphenol Formulation |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
Time frame: 14 days
Change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. The responses to the questions range from no discomfort at all to very severe discomfort which would indicate a worse outcome
Gut Microbiome Stool Test
Time frame: 14 days
Change in the Gut Microbiome (strain level, functional metrics, taxonomy abundance and composition) from baseline
5 secondary outcomes
Digestion-Associated Quality of Life Questionnaire (DQLQ)
Time frame: 14 days
Visual Analogue Scale (VAS) of abdominal pain
Time frame: 14 days
Bristol Stool Form Scale (BSFS)
Time frame: 14 days
Gastrointestinal -Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Time frame: 14 days
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: 14 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 26 Aug 2026.
- BackgroundAdministration, D. o. H. a. H. S. U. S. F. a. D. (2005). Guidance for industry : estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers : pharmacology and toxicology. Center for Drug Evaluation and Research.
- 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.
- Background: PubMed 40635319Cristofori F, Calabrese FM, Iacobellis I, Santamaria M, Celano G, Ferrocino I, Di Sabato E, Pergola R, Dargenio VN, Paulucci L, De Angelis M, Francavilla R. Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial. J Pediatr Gastroenterol Nutr. 2025 Sep;81(3):551-561. doi: 10.1002/jpn3.70154. Epub 2025 Jul 9.
- 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), A23.
- BackgroundHodges, J. Z., 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, 981. https://doi.org/10.1093/cdn/nzac068.010
- Background: PubMed 36502573Hodgkinson 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.
- Background: PubMed 32807722Huang Q, Braffett BH, Simmens SJ, Young HA, Ogden CL. Dietary Polyphenol Intake in US Adults and 10-Year Trends: 2007-2016. J Acad Nutr Diet. 2020 Nov;120(11):1821-1833. doi: 10.1016/j.jand.2020.06.016. Epub 2020 Aug 15.
- BackgroundKapolou, A. K. H. R., N; Koutelidakis, A. (2021). Association of Mean Daily Polyphenols Intake with Mediterranean Diet Adherence and Anthropometric Indices in Healthy Greek Adults: A Retrospective Study. Applied Sciences, 11(10). https://doi.org/10.3390/app11104664
- Background: PubMed 32213021Ljotsson B, Jones M, Talley NJ, Kjellstrom L, Agreus L, Andreasson A. Discriminant and convergent validity of the GSRS-IBS symptom severity measure for irritable bowel syndrome: A population study. United European Gastroenterol J. 2020 Apr;8(3):284-292. doi: 10.1177/2050640619900577. Epub 2020 Jan 14.
- 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, PhD 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 + 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 9 inclusion and 28 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 26 Aug 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?
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version (time frame: 14 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 NCT07371975, which also lists 19 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 26 Aug 2026.