[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Roaa Ahmed Alkreadees\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100574882","phase-2-effect-of-probiotics-psychobiotics-on-depression-and-metabolic-syndrome-in-saudi-arabia-100574882",false,"NCT06765057","Effect of Probiotics \"Psychobiotics\" on Depression and Metabolic Syndrome in Saudi Arabia","Effect of Probiotics \"Psychobiotics\" on Depression in Adults With Pre-Metabolic Syndrome and Metabolic Syndrome in Riyadh City","Inclusion Criteria:\n\n* Major Depression Disorder (MDD) patients on antidepressants for at least 4 weeks or more.\n* MDD patients with pre-metabolic syndrome (at least 2 of the MetS components) and metabolic syndrome (at least 3 of the following components: central obesity with WC for men ≥ 94 centimeters while for women ≥ 80 centimeter, increased FPG ≥ 100 mg\u002Fdl, increased BP to ≥ 130 \u002F ≥ 85 mmHg, increased TGs equal or above 150 mg \u002F dl, increased HDL cholesterol for men to \\\u003C 40 mg \u002F dl while for women \\\u003C 50 mg \u002F dl) (IDF., 2006).\n* MDD patients with other comorbid diseases such as anxiety.\n\nExclusion Criteria:\n\n* Patients using any other supplements to improve mood.\n* Patients using pre\u002Fpro\u002Fsymbiotics supplement or antibiotics during the last 3 weeks before the intervention.\n* Patients with chronic diseases (cardiac, renal, or hepatic diseases)\n* Patients with gastro intestinal diseases (Crohn's disease, ulcerative colitis).\n* Patients with infectious diseases (HIV\u002FAIDS).\n* Cancer patients or those undergoing chemotherapy.\n* Patients with food allergies such as gluten intolerance or lactose intolerance.\n* Pregnant and breastfeeding women.\n* Patients with modified antidepressant dose during interventional period or receiving psychotherapy during the intervention.\n* Patients with thyroid disorder.\n* Patients following a diet to lose weight during the intervention.\n* Diabetic patients who are insulin-dependent.\n* patients receiving injections or medications to lose weight (Ozempic, Mounjaro …etc) either 3 weeks before or during the intervention.\n* Patients using plasma-lipid lowering drug for less than 1 month before the intervention.\n* Patients with substance abuse including alcohol addiction.","ALL","18 Years","65 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The goal of this clinical trial is to assess the effect of commercial multi-strains psychobiotics supplementation as an ad-on therapy on depressive symptoms and metabolic syndrome components (HDL-C, FPG, TGs, WC, BP) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The second goal is to explore the effect of commercial multi-strains psychobiotics supplementation on the anthropometric measurement (weight, body mass index (BMI)) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The main questions they aim to answer are:\n\n* Will commercial multi-strains psychobiotics supplementation help to ease depressive symptoms as an ad-on therapy in patients with pre-metabolic syndrome and metabolic syndrome?\n* Will commercial multi-strains psychobiotics supplementation improve anthropometric measurements and metabolic syndrome components (WC, FPG, BP, TGs, HDL-C) in depressed patients? Researchers will compare psychobiotics to a placebo (a look-alike substance that contains no drug) to see if psychobiotics work to improve depression and metabolic syndrome components.\n\nParticipants will:\n\n* Be examined for depression, anxiety, and metabolic syndrome components (waist circumference, diabetes, blood pressure, triglycerides, and high-density lipoprotein).\n* Be asked to conduct laboratory tests to determine the inclusion and exclusion criteria.\n* Be given probiotics\u002F placebo to consume every day for 3 months (12 weeks).\n* Repeat the examination and laboratory tests to determine the results.\n* Be followed up weekly for adverse events and to insure their compliance with the study instructions.\n* Be followed up after 4 weeks as an end-visit and will conduct the examination and the laboratory blood tests.",[28],"Depression Anxiety Disorder","RECRUITING","2025-09-16",{"date":32,"type":33},"2025-09-22","ACTUAL",{"date":35,"type":33},"2025-03-02",{"date":37,"type":21},"2027-01-30",{"name":39,"class":40},"Roaa Ahmed Alkreadees","OTHER_GOV",""]