[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digestive-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digestive-disorders":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100172884","product-surveillance-registry-100172884",false,"NCT01524276","Product Surveillance Registry","Medtronic Product Surveillance Registry","PSR","Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment\n\nExclusion Criteria:\n\n* Patient who is, or will be, inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results","ALL",{"count":19,"type":20},100000,"ESTIMATED","OBSERVATIONAL","The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Cardiac Rhythm Disorders","Urological Disorders","Neurological Disorders","Cardiovascular Disorders","Digestive Disorders","Intracranial Aneurysm","Mechanical Circulatory Support","Respiratory Therapy","Aortic, Peripheral Vascular and Venous Disorders","Minimally Invasive Surgical Procedures","Diagnostic Techniques and Procedures","Surgical Procedures, Operative","Renal Insufficiency","Neurovascular","Coronary Artery Disease","Ear, Nose and Throat Disorder","RECRUITING","2026-06-15",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":4},"2012-01",{"date":48,"type":20},"2040-01",{"name":50,"class":51},"Medtronic","INDUSTRY",395,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100609341","probiotic-intervention-for-digestive-health-in-obese-patients-initiating-glp-ra-treatment-100609341","NCT07213323","Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment","Evaluation of the Efficacy of Probiotics on Digestive Quality of Life in Patients Initiating GLP-1 Receptor Agonists for the Treatment of Obesity. A Randomized, Double-blind Trial","PROBIO-GLP1","Inclusion Criteria:\n\n* Patient who is going to start a GLP-1 RA (semaglutide or tirzepatide) for weight management\n* Men or Women\n* BMI ≥ 30 kg\u002Fm2 or BMI ≥ 27 kg\u002Fm2 associated with one or more co-morbidities (arterial hypertension, sleep apnea, dyslipidemia, arthritis)\n* Between 18 and 75 years old\n* In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, ability to understand and fill the self-rating scales, drug compliance, availability to attend to the scheduled visits, etc…).\n* Patient who agrees to be included in the study and who signs the informed consent form\n* Female participants of childbearing potential must agree to use effective contraception\n* Patient affiliated to a healthcare insurance plan\n\nExclusion Criteria:\n\nCriteria relating to the study population:\n\n* Patients under 18 years old\n* Patient with contraindication to semaglutide or tirzepatide according to the Summary of Product Characteristics (SPC).\n* Patients scheduled for bariatric surgery during the study period\n* Patients who have had bariatric surgery in the last 12 months\n* Patient with a current diagnosis of diabetes.\n* Patients with a current diagnosis of liver cirrhosis, short bowel syndrome or inflammatory bowel disease (IBD).\n* Patients with severely weakened immune system.\n* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.\n\nProduct criteria:\n\nPatient with known allergy to the product of the study\n\nProhibited treatments :\n\nCurrent associated treatments or used in the last 30 days: GLP-1 RA, Anti-obesity drugs (AOD), Corticosteroids, Atypical neuroleptics, Antibiotics, Probiotics, Prebiotics\n\nRegulatory criteria :\n\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons under psychiatric care\n* Persons admitted to a health or social institution for purposes other than research\n* Adults subject to a legal protection measure (guardianship, curatorship)\n* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n* Subjects participating in other interventional research with an exclusion period still in progress at pre-inclusion","18 Years","75 Years",{"count":64,"type":20},50,"INTERVENTIONAL",[67],"NA","Obesity is a prevalent chronic disease affecting 17% of the French population. Treatment involves multiple factors, with pharmacotherapy playing an increasingly important role. GLP-1 receptor agonists (GLP1 RAs) are considered revolutionary in obesity treatment, with three approved molecules available in France: liraglutide, semaglutide, and tirzepatide. These treatments, combined with a healthy lifestyle, induce significant weight loss: 9% with liraglutide, 15% with semaglutide, and 20% with tirzepatide.\n\nThe most common adverse events (AEs) associated with GLP-1 RAs are gastrointestinal (GI) disorders, including nausea, vomiting, diarrhea, and abdominal pain. These AEs are dose-dependent and often decline over time. In phase 3 trials, semaglutide 2.4 mg showed higher rates of GI AEs compared to placebo, but most were mild to moderate and transient. GI AEs led to dose reduction or temporary treatment interruption in 12.5% of participants, with few permanent discontinuations.\n\nProbiotics, are live microorganisms that benefit the host by improving gut microflora. Probiotics has been clinically proven to benefit gastrointestinal health. Probiotics may reduces symptoms of irritable bowel syndrome (IBS), improves gut barrier function, reduces inflammation, and decreases the incidence of C. difficile infection (CDI) in patients taking antibiotics.\n\nProbiotics is therefore theorized to potentially reduce GI side effects associated with GLP-1 RA treatment for obesity.\n\nHypothesis Probiotics will prevent and limit the digestive disorders induced by GLP-1 R agonists, particularly during the dose escalation period. This would allow better digestive tolerance of the treatments, limiting the number of definitive treatment interruptions, facilitating compliance and dose escalation with a larger number of subjects at full dose and therefore with better systemic exposure to the compounds, a key factor in their effects on weight loss.",[70,28],"Obesity &Amp; Overweight",[72,73,74],"GLP1 R-agonist","Probiotics","Quality of life","NOT_YET_RECRUITING","2025-10-01",{"date":78,"type":44},"2025-10-08",{"date":80,"type":20},"2025-12-15",{"date":82,"type":20},"2027-12-15",{"name":84,"class":85},"Hospices Civils de Lyon","OTHER",1]