[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637611":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":99,"collaborators":101,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":42,"studyType":123,"phases":124,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic intervention","EXPERIMENTAL","This group uses a probiotic formulation to prevent metabolic risk factors of antipsychotics",[13],"Dietary Supplement: Probiotic Formula",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","This group uses a placebo",[19],"Dietary Supplement: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Probiotic Formula","After informed consent, participants will be randomized 1:1 to either:\n\n* Intervention group: Ecologic® Barrier\n* Control group: Placebo powder (identical in appearance, taste, and packaging but without active bacterial strains)\n\nEcologic® Barrier\n\n* Dosage form: Powder formulation containing a multi-strain probiotic mixture\n* Dosage: Standard manufacturer-recommended dose per sachet\n* Frequency: Twice daily (morning and evening)\n* Route of administration: Oral, dissolved in water or another non-carbonated beverage\n* Duration: 12 weeks (3 months)\n* Distinguishing characteristics:\n* Contains a defined combination of probiotic strains specifically formulated to support gut ba- rrier integrity\n* Delivered as a powder sachet to ensure stability of live bacterial cultures\n* Designed to modulate gut-brain axis pathways relevant to antipsychotic-associated metabolic effects",[9],[27],"Ecologic Barrier",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"* Dosage form: Powder identical in appearance, texture, and packaging to the active product\n* Dosage: One sachet per administration\n* Frequency: Twice daily\n* Route of administration: Oral\n* Duration: 12 weeks\n* Distinguishing characteristics:\n* Contains no active probiotic strains\n* Formulated to match the organoleptic properties of Ecologic® Barrier to maintain blinding",[15],[32],"Placebo formulation",[34],{"name":35,"affiliation":5,"role":36},"Iris E.C. Sommer, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Toon A.W. Scheurink, MSc","CONTACT","+31681528283",null,"a.w.scheurink@umcg.nl",[45,69,82],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"KieN VIP Leeuwarden","RECRUITING","Leeuwarden","Provincie Friesland","8911KJ","Netherlands","NL",{"type":54,"coordinates":55},"Point",[56,57],5.80973,53.20271,{"lat":57,"lon":56},[60,64,67],{"name":61,"role":40,"phone":62,"phoneExt":42,"email":63},"Marrit Wiersma","+31614734656","marrit@kien.nu",{"name":65,"role":40,"phone":62,"phoneExt":42,"email":66},"Hesra Bijen","bijenhesra@gmail.com",{"name":68,"role":36,"phone":42,"phoneExt":42,"email":42},"Nynke Boonstra, PhD",{"facility":5,"status":47,"city":70,"state":71,"zip":72,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Groningen","Provincie Groningen","9713GZ",{"type":54,"coordinates":74},[75,76],6.56667,53.21917,{"lat":76,"lon":75},[79,80],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":81,"role":36,"phone":42,"phoneExt":42,"email":42},"Iris E.C. Sommer, MD, PhD",{"facility":83,"status":47,"city":84,"state":85,"zip":86,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Antes Parnassia Groep","Rotterdam","South Holland","3083AK",{"type":54,"coordinates":88},[89,90],4.47917,51.9225,{"lat":90,"lon":89},[93,97],{"name":94,"role":40,"phone":95,"phoneExt":42,"email":96},"Yunus A.W. Yalcin, PhD","+310613434115","y.yalcin@parnassiagroep.nl",{"name":98,"role":36,"phone":42,"phoneExt":42,"email":42},"Nico van Beveren, MD, PhD",{"type":100,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[102,105,107],{"name":103,"class":104},"The Dutch Brain Foundation (funding)","UNKNOWN",{"name":106,"class":6},"Parnassia Groep",{"name":108,"class":104},"KienVIP","100637611","phase-2-no-guts-no-glory-probiotics-100637611",false,"NCT07606014","No Guts No Glory Probiotics","Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind Trial","NGNGP","Inclusion Criteria:\n\n1. About to start, or having started within the last 8 weeks, antipsychotic treatment with olanzapine, quetiapine\\*, clozapine or risperidone for treating psychosis\n2. Aged between 18 - 65\n3. No exposure to these four antipsychotic medications for longer than one week continuously in the last 6 months (except starting the treatment with the current medication 8 weeks prior to the inclusion)\n4. The participant understands the study and is able to provide written informed consent.\n\n   * Quetiapine prescribed in a low dose for use as a sleep aid does not apply\n\nExclusion Criteria:\n\n1. Critically ill patients (e.g. ICU), diagnosed comorbid eating disorders, chronic GI-disorders, disorders of the liver or pancreas, pre-existing diagnosed diabetes mellitus or metabolic syndrome\n2. Current use of medications known to target metabolism or weight (e.g, diabetes medication and GLP-1 agonists, proton pump inhibitors and diuretics\u002Fbeta blockers) or use of antibiotics or probiotics (such as Yakult, Activia, or other probiotic supplements containing ≥10⁹ CFUs) in the past 4 weeks\n3. Pregnancy or breastfeeding\n4. Inability to follow the intervention or other conditions that according to the investigator might interfere with the evaluation of the study objectives as judged by the treating physician","ALL","18 Years","65 Years",{"count":121,"type":122},112,"ESTIMATED","INTERVENTIONAL",[125,126],"PHASE2","PHASE3","The goal of this clinical trial is to learn if probiotics work to prevent or reduce metabolic side effects caused by antipsychotic medication in adults.\n\nThe main question it aims to answer is:\n\nDo probiotics reduce weight gain, blood sugar levels, and blood fat levels in people using antipsychotics?\n\nResearchers will compare a probiotic (Ecologic® Barrier) to a placebo (a look-alike powder without active bacteria) to see if the probiotic is effective.\n\nParticipants will:\n\nTake either probiotics or a placebo daily for 12 weeks (3 months) Dissolve two sachets in water and drink them each morning Visit the clinic (or receive home visits) four times: at the start, after 6 weeks, and after 12 weeks, plus an initial screening visit Undergo physical measurements (e.g., weight, blood pressure), complete questionnaires, and perform a cognitive test at specific visits Provide blood samples and stool samples at the beginning and end of the study Complete two 3-day food diaries during the study",[129],"Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine",[131,132,133,134,135,136,137,138,139,140,141,142],"Antipsychotics","Probiotics","Psychosis","Schizophrenia","Metabolic syndrome","HbA1c","Blood glucose","Weight gain","Olanzapine","Quetiapine","Risperidone","Clozapine","2026-05-18",{"date":145,"type":146},"2026-05-26","ACTUAL",{"date":148,"type":122},"2026-06-01",{"date":150,"type":122},"2029-05-01",{"name":5,"class":6},3]