[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597725":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":42,"locations":50,"responsibleParty":73,"collaborators":33,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":33,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":104,"whyStopped":33,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Universidad Católica San Antonio de Murcia","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Type 1 Diabetes - Supplement","EXPERIMENTAL","Participants with type 1 diabetes mellitus will receive a daily 10 mL gel supplement containing 4000 mg of inulin and 1000 mg of tyndallized probiotics for approximately 98 days. The supplement is designed to modulate gut microbiota and improve glycemic control.",[13],"Dietary Supplement: Probiotic\u002FPrebiotic Supplement",{"label":15,"type":10,"description":16,"interventionNames":17},"Type 1 Diabetes - Placebo","Participants with type 1 diabetes mellitus will receive a daily 10 mL placebo gel without active ingredients for approximately 98 days. The placebo is organoleptically identical to the supplement to maintain blinding.",[18],"Dietary Supplement: Placebo Gel",{"label":20,"type":10,"description":21,"interventionNames":22},"Healthy Controls - Supplement","Healthy participants will receive a daily 10 mL gel supplement containing 4000 mg of inulin and 1000 mg of tyndallized probiotics for approximately 98 days. This arm allows comparison of microbiota and metabolic responses between diabetic and non-diabetic individuals.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Healthy Controls - Placebo","Healthy participants will receive a daily 10 mL placebo gel without active ingredients for approximately 98 days. The placebo is identical in appearance and flavor to the active supplement.",[18],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIETARY_SUPPLEMENT","Probiotic\u002FPrebiotic Supplement","Oral dietary supplement in gel form (10 mL per day) containing 4000 mg of inulin and 1000 mg of tyndallized probiotics. Administered once daily for approximately 98 consecutive days. Produced by Martínez Nieto S.A. (MARNYS®). Intended to modulate gut microbiota and improve glycemic and inflammatory markers.",[20,9],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Placebo Gel","Oral placebo in gel form (10 mL per day), identical in appearance, texture, and taste to the active supplement, but without probiotic or prebiotic components. Administered once daily for 98 days to maintain blinding and control effects.",[24,15],[39],{"name":40,"affiliation":5,"role":41},"María T Mercader Ros, PhD","PRINCIPAL_INVESTIGATOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":33,"email":46},"CONTACT","+349682785523","mtmercader@ucam.edu",{"name":48,"role":44,"phone":45,"phoneExt":33,"email":49},"Pablo M Barcina Pérez, PhD","pbarcina@ucam.edu",[51],{"facility":52,"status":33,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"UCAM San Antonio Catholic University of Murcia","Murcia","30107","Spain","ES",{"type":58,"coordinates":59},"Point",[60,61],-1.13004,37.98704,{"lat":61,"lon":60},[64,68,69,71],{"name":65,"role":44,"phone":66,"phoneExt":33,"email":67},"San Antonio Catholic University of Murcia UCAM","(+34) 968 27 88 00","info@ucam.edu",{"name":40,"role":41,"phone":33,"phoneExt":33,"email":33},{"name":48,"role":70,"phone":33,"phoneExt":33,"email":33},"SUB_INVESTIGATOR",{"name":72,"role":70,"phone":33,"phoneExt":33,"email":33},"Inmaculada Llopis",{"type":41,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Mª Teresa Mercader Ros","Principal Investigator and Academic Secretary of the Bachelor's Degree in Human Nutrition and Dietetics at UCAM","100597725","effect-of-a-probiotic-supplement-on-gut-microbiota-and-glycemic-control-in-patients-with-type-1-diabetes-prodiab-100597725",false,"NCT07062224","Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)","Impact of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial","PRODIAB","Inclusion Criteria:\n\n* Age between 18 and 65 years.\n* Ability to understand and sign the informed consent form.\n* For the patient group: diagnosis of type 1 diabetes with at least 1 year of disease progression.\n* For the control group: healthy individuals without a diagnosis of diabetes or other metabolic disorders.\n* No use of antibiotics, probiotics, or prebiotics during the 4 weeks prior to the study start.\n* Willingness to comply with the study protocol and attend scheduled visits.\n\nExclusion Criteria:\n\n* Current use of probiotics, prebiotics, or antibiotics.\n* Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome).\n* Pregnancy or breastfeeding.\n* Participation in another clinical trial within the past 3 months.\n* Immunosuppressive diseases, active cancer, or treatment with immunosuppressants.\n* Known allergy or intolerance to any component of the supplement or placebo.\n* Excessive alcohol or drug use.",true,"ALL","18 Years","65 Years",{"count":89,"type":90},80,"ESTIMATED","INTERVENTIONAL",[93],"NA","This randomized, double-blind clinical trial aims to evaluate the effect of a probiotic supplement on gut microbiota composition and glycemic control in adults with type 1 diabetes mellitus. A secondary comparison will be made with a healthy control group. Participants will be assigned to receive either a probiotic or a placebo for 98 days. Stool samples and metabolic parameters will be collected at baseline and after the intervention period. The study seeks to better understand how modulation of the intestinal microbiota may influence glucose regulation in people with type 1 diabetes.",[96],"Diabete Type 1",[98,99,100,101,102,103],"Gut microbiota","Probiotic supplement","Zonulin","Calprotectin","Type 1 Diabetes","Glycemic Control","NOT_YET_RECRUITING","2025-07-02",{"date":107,"type":108},"2025-07-14","ACTUAL",{"date":110,"type":90},"2025-09",{"date":112,"type":90},"2025-12",{"name":5,"class":6},1]