[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639426":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":30,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":93,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The Archer-Daniels-Midland Company","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic","EXPERIMENTAL","Participants in this arm will receive a daily dose of a daily dose of of a probiotic (live bacterium), in a form of 2 capsules once daily, for 28 days.",[13],"Dietary Supplement: Probiotic",{"label":15,"type":10,"description":16,"interventionNames":17},"Postbiotic","Participants in this arm will receive a daily dose of a postbiotic (heat-inactivated bacterium), in a form of 2 capsules once daily, for 28 days.",[18],"Dietary Supplement: Postbiotic",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Participants in this arm will receive an equivalent placebo for the duration of the study (28 days).",[24],"Dietary Supplement: Placebo",[26,31,33],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Participants in this arm will receive a daily dose of of a probiotic (live bacterium), in a form of 2 capsules once daily, for 28 days.",[9],null,{"type":27,"name":15,"description":16,"armGroupLabels":32,"otherNames":30},[15],{"type":27,"name":20,"description":22,"armGroupLabels":34,"otherNames":30},[20],[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"ADM Medical Team","CONTACT","+441460243230","medical@protexin.com",[42],{"facility":43,"status":30,"city":44,"state":30,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"General Hospital of Thessaloniki Papageorgiou","Thessaloniki","56429","Greece","GR",{"type":49,"coordinates":50},"Point",[51,52],22.93493,40.64072,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":57,"phoneExt":30,"email":58},"Theodoridou","+30 210 6147282","maria.theodoridou@nextcro.eu",{"type":60,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[62],{"name":63,"class":64},"NEXT CRO","UNKNOWN","100639426","effect-of-a-probiotic-or-postbiotic-on-gut-microbiome-during-antibiotic-treatment-100639426",false,"NCT07594860","Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment","Assessment Of Gut Microbiome Changes During Antibiotic Treatment With Probiotic, Postbiotic Or Placebo: A Randomized, Triple-blind, Placebo-controlled Pilot Study.","POTATO-2","Inclusion Criteria:\n\nParticipants meeting ALL of the following criteria will be recruited for the study:\n\n* Males and females aged ≥18 to ≤ 65 years; if female, either not of childbearing potential or using a medically approved method of birth control and willing to take a pregnancy test at screening.\n* Body mass index (BMI) 18.5-29.9 kg\u002Fm².\n* Healthy as determined by medical history and physical examination.\n* Agreed not to change current dietary habits during the course of the study.\n* Able to attend study visits, comply with study requirements (consumption of study medications, especially biological sample collection procedures, and study visit schedule) and provide reliable and complete data regarding AEs\u002FSAEs and PROs.\n* Have been informed and have given written consent for the use of their data in accordance with local regulations before study inclusion.\n\nExclusion Criteria:\n\nParticipants meeting ANY of the following criteria will be excluded from the study:\n\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the study.\n* People on vegetarian or vegan diet; People on special diet (e.g. Ducan, Keto, etc.)\n* BMI ≥ 30 kg\u002Fm² or \\\u003C18.5 kg\u002Fm².\n* History of intake of antibiotics, other probiotics, postbiotics, prebiotics, synbiotics, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), within six months prior to the screening day.\n* Participation in other clinical trials in the last 90 days prior to screening.\n* Allergy to any penicillin antibiotic or any other beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam).\n* History of jaundice\u002Fhepatic impairment due to amoxicillin\u002Fclavulanic acid.\n* Active smokers or using any form of smokeless tobacco.\n* Participants with substance abuse problems (within two years) defined as:\n\n  * Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)\u002F Nicotine dependence.\n  * High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol-containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol-containing beverages per week for men.\n* Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and\u002For any inflammatory disorder, tumour, and other gastrointestinal diseases.\n* Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.\n* Participants actively using GLP1 agonist drugs (Wegovy, Semiglutide etc.) or completed treatment with said medication less than 12 weeks before screening.\n* Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.",true,"ALL","18 Years","65 Years",{"count":78,"type":79},126,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study assesses the effects of a probiotic or postbiotic on gut microbiome during antibiotic treatment.",[85],"Microbiome",[87,88,89,90,91,92,9,15],"Antibiotic","Dysbiosis","Microbiome composition","Antibiotic Resistance Genes","Microbiome Recovery","Antibiotic Scarring","NOT_YET_RECRUITING","2026-05-12",{"date":96,"type":97},"2026-05-19","ACTUAL",{"date":99,"type":79},"2026-06-01",{"date":101,"type":79},"2027-05-31",{"name":5,"class":6},1]