[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":16,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":16,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":16,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":43,"whyStopped":16,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Supplement Formulators, Inc.","INDUSTRY",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Butyrate + Polyphenol Formulation","ACTIVE_COMPARATOR",[12],"Dietary Supplement: Butyrate + Polyphenol Formulation",{"label":14,"type":15,"description":16,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",null,[18],"Dietary Supplement: Placebo",[20,23],{"type":21,"name":9,"description":9,"armGroupLabels":22,"otherNames":16},"DIETARY_SUPPLEMENT",[9],{"type":21,"name":14,"description":14,"armGroupLabels":24,"otherNames":16},[14],[26],{"name":27,"affiliation":28,"role":29},"Andrew Swick, PhD","Life Extension","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":16,"email":35},"Steven Hirsh","CONTACT","9542027679","shirsh@lifeextension.com",{"name":37,"role":33,"phone":38,"phoneExt":16,"email":39},"Barbara Martinez","9542842709","bmartinez@lifeextension.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Life Extension Clinical Research, Inc.","RECRUITING","Fort Lauderdale","Florida","33304","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-80.14338,26.12231,{"lat":53,"lon":52},[56,58,59],{"name":32,"role":33,"phone":57,"phoneExt":16,"email":35},"954-202-7679",{"name":37,"role":33,"phone":38,"phoneExt":16,"email":39},{"name":27,"role":29,"phone":16,"phoneExt":16,"email":16},{"type":61,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100621542","a-study-to-evaluate-the-effects-of-a-butyrate-polyphenol-formulation-on-gut-health-and-associated-symptoms-100621542",false,"NCT07371975","A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms","Inclusion Criteria:\n\n1. Male or female, age 25-70 years\n2. Body mass index 18.5-34.9 kg\u002Fm2\n3. A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is \\\u003C 20 (identification of minimal or mild), may be included at the discretion of the PI\u002FSub-I\n4. Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)\n5. Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI\u002FSub-I)\n6. Weight stable for the past six months (±6 lbs.)\n7. Willing and able to give written informed consent\n8. Ability to communicate and read in English\n9. Ability to comply with study requirements\n\nExclusion Criteria:\n\n1. Currently participating in another clinical research study\n2. Pregnant, planning pregnancy, or breastfeeding\n3. Unable to swallow capsules, tablets, or softgels\n4. 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.\n5. Typically goes longer than 3 days without a bowel movement\n6. 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\n7. Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.\n8. Planning to undergo a major medical procedure or surgical event within the next 30 days\n9. Currently being treated for any infectious disease\n10. 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\u002Fcan of beer, one glass of wine, or one ounce of hard liquor)\n11. Smoking or use of nicotine products daily within 30 days prior to screening\n12. Using substances of abuse or recreational drugs\u002Fsubstances, including tetrahydrocannabinol (THC), within the past 14 days\n13. 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)\n14. Having donated blood or received a blood\u002Fplasma transfusion within 30 days before baseline\n15. History of a major change in dietary habits within the past 1 month\n16. Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation\n17. Currently taking any laxatives on a daily basis\n18. Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.\n19. On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.\n20. History of oral or IV antibiotic use within the past 3 months prior to Baseline\n21. 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\u002FSub-I\n22. 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\n23. Currently diagnosed with and\u002For being treated for Irritable Bowel Syndrome (IBS)\n24. Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month\n25. Currently experiencing or previously having a parasitic infection within the past 3 months\n26. Currently experiencing or having a history of severe endometriosis\n27. History of gastrointestinal surgery, which might influence gastrointestinal function\n28. History or presence of a clinically significant diagnosis or circumstance that, in the judgment of the Study Investigator\u002FSub-I, would interfere with the interpretation of the study results and preclude participation in the study -",true,"ALL","25 Years","70 Years",{"count":73,"type":74},124,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of the study is to evaluate the efficacy of a butyrate\u002Fpolyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.",[80],"Gut Health",[82,83,84,85,86,87],"Gastrointestinal discomfort","Abdominal pain","Gas","Bloating","Diarrhea","Constipation","2026-01-27",{"date":90,"type":91},"2026-01-29","ACTUAL",{"date":93,"type":91},"2025-10-16",{"date":95,"type":74},"2026-07-30",{"name":5,"class":6},1]