[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653219":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":11,"studyPopulation":11,"armGroups":36,"interventions":48,"overallOfficials":11,"centralContacts":58,"locations":68,"responsibleParty":86,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":11,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":116,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University Maribor","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Hamilton Depression Rating Scale (HAM-D-17) score from baseline to Week 12",null,"12 weeks",[14,16,18,20,22],{"measure":15,"description":11,"timeFrame":12},"Change in Beck Depression Inventory-II (BDI-II) score from baseline to Week 12",{"measure":17,"description":11,"timeFrame":12},"Change in Perceived Stress Scale (PSS-10) score from baseline to Week 12",{"measure":19,"description":11,"timeFrame":12},"Changes in gut microbiome composition and diversity (α-diversity, β-diversity and relative abundance of bacterial taxa) between baseline and Week 12",{"measure":21,"description":11,"timeFrame":12},"Safety and tolerability of probiotic supplementation, assessed by adverse events and treatment discontinuation",{"measure":23,"description":11,"timeFrame":12},"Less sick leave days corresponding with a change of HAMD-17 score from baseline to 12 weeks",{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"RANDOMIZED","PARALLEL","One group receiving the probiotics, the other placebo. Both groups will receive probiotics\u002Fplacebo from the psychiatrist, they will look and taste the same and non of them will know what the specific patient received.","TREATMENT",{"masking":30,"maskingDescription":11,"whoMasked":31},"QUADRUPLE",[32,33,34,35],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"OMNi-BiOTiC STRESS Repair","EXPERIMENTAL","Stable antidepressant therapy plus OMNi-BiOTiC STRESS Repair for 12 weeks",[42],"Dietary Supplement: OMNi-BiOTiC® STRESS Repair",{"label":44,"type":45,"description":11,"interventionNames":46},"Control group","PLACEBO_COMPARATOR",[47],"Other: Matched Placebo Powder for Oral Solution",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"DIETARY_SUPPLEMENT","OMNi-BiOTiC® STRESS Repair","Participants will receive one 3-g sachet orally once daily for 12 weeks, in addition to their existing stable antidepressant therapy. Each 3-g sachet contains at least 7.5 × 10⁹ viable bacteria from nine strains: Lactobacillus casei W56, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Bifidobacterium animalis subsp. lactis W51, Lactobacillus salivarius W24, Lactococcus lactis W19, Bifidobacterium animalis subsp. lactis W52, Lactobacillus plantarum W62, and Bifidobacterium bifidum W23. The powder will be mixed with 100-200 mL of water, allowed to activate for at least one minute, stirred again, and consumed, preferably on an empty stomach. Participants will continue the same antidepressant medication and dose throughout the intervention period unless a change is clinically required.",[38],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"Matched Placebo Powder for Oral Solution","Participants will continue stable antidepressant therapy and receive a matched placebo for 12 weeks.",[44],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":11,"email":63},"Tomo Brus Hladen, MD","CONTACT","00386 2 62 10 743","tomo.brus.hladen@zd-gr.si",{"name":65,"role":61,"phone":66,"phoneExt":11,"email":67},"Andreja Čelofiga, PhD, MD","00386 2 321 1115","andreja.celofiga@ukc-mb.si",[69],{"facility":70,"status":11,"city":71,"state":11,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Zdravstveni dom Gornja Radgona","Gornja Radgona","9250","Slovenia","SI",{"type":76,"coordinates":77},"Point",[78,79],15.99219,46.67263,{"lat":79,"lon":78},[82],{"name":83,"role":61,"phone":84,"phoneExt":11,"email":85},"Psihiatrična ambulanta","00386 2 564 8600","narocanje.psihiater@zd-gr.si",{"type":87,"investigatorFullName":60,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","MD",[90],{"name":91,"class":92},"Institut AllergoSan","UNKNOWN","100653219","adjunctive-probiotic-therapy-in-major-depressive-disorder-a-randomized-controlled-trial-promood-100653219",false,"NCT07786285","Adjunctive Probiotic Therapy in Major Depressive Disorder: A Randomized Controlled Trial (ProMOOD)","ProMOOD","Inclusion Criteria:\n\n\\- Age 18-65 years\n\n* Confirmed diagnosis of depression according to ICD 11 (International Classification of Diseases) criteria\n* Written informed consent\n* Stable antidepressant therapy (same medication for at least 6 weeks to ensure stable clinical response)\n\nExclusion Criteria:\n\n* \\- Acute suicidality\n* Severe cardiovascular disease\n* Pregnancy or breastfeeding\n* Substance\u002F alcohol abuse\n* Severe neurological or systemic disease\n* Recent antibiotic use\n* Probiotic use in past year\n* Treatment resistant depression\n* Psychotic depression","ALL","18 Years","65 Years",{"count":104,"type":105},200,"ESTIMATED","INTERVENTIONAL",[108],"NA","A double-blind, randomized controlled trial (RCT) aimed at evaluating the efficacy of probiotic supplementation in patients undergoing concurrent antidepressant therapy.\n\nThe study will also assess gut microbiome composition and function, and correlate microbiome changes with clinical and psychological outcomes.\n\nParticipants will be evaluated by a psychiatrist\u002Fclinician, alongside standardized psychological assessments at:\n\n* Baseline (inclusion)\n* Week 4\n* Week 12\n\nThe following validated instruments will be used:\n\n* HAM-D - Hamilton Depression Rating Scale (clinician-rated depression severity)\n* BDI - Beck Depression Inventory (self-reported severity of depression)\n* PSS - Perceived Stress Scale (self-reported stress perception)\n\nInclusion Criteria\n\n* Age 18-65 years\n* Confirmed diagnosis of depression according to ICD 11 (International Classification of Diseases) criteria\n* Written informed consent\n* Stable antidepressant therapy (same medication for at least 6 weeks to ensure stable clinical response)\n\nExclusion Criteria\n\n* Acute suicidality\n* Severe cardiovascular disease\n* Pregnancy or breastfeeding\n* Substance\u002F alcohol abuse\n* Severe neurological or systemic disease\n* Recent antibiotic use\n* Probiotic use in past year\n* Treatment resistant depression\n* Psychotic depression\n\nSample Size\n\n* Initial recruitment target: 150-200 participants\n* Expected dropout rate: approximately 50%, based on similar studies\n* Final expected sample size: \\~100 participants\n* Sample size calculation based on Nikolova et al., 2023.\n\nPrimary outcome Change in Hamilton Depression Rating Scale (HAM-D-17) score from baseline to Week 12.\n\nSecondary outcomes Change in Beck Depression Inventory-II (BDI-II) score from baseline to Week 12. Change in Perceived Stress Scale (PSS-10) score from baseline to Week 12. Changes in gut microbiome composition and diversity (α-diversity, β-diversity and relative abundance of bacterial taxa) between baseline and Week 12.\n\nSafety and tolerability of probiotic supplementation, assessed by adverse events and treatment discontinuation.\n\nIntervention:\n\nOmniBiotic Stress Repair\n\nMicrobiome Analysis Subgroup\n\nStool samples will be collected at:\n\n* Baseline\n* 1 month\n* 3 months Analysis will follow methodologies similar to Mörkl S et al. (2025).\n\nRemark: Additional sampling at 1 week (as done in the referenced study) is considered unnecessary, as it falls outside routine clinical monitoring.\n\nAntidepressant Strategy\n\n* Include patients receiving SSRI (Selective Serotonin Reuptake Inhibitors) and possibly SNRI (Serotonin-Norepinephrine Reuptake Inhibitors)\n* Advantage: broader applicability\n* Limitation: increased variability",[111],"Depression \u002F Major Depressive Disorder",[113,114,115],"depression","probiotics","randomized controlled study","NOT_YET_RECRUITING","2026-08-21",{"date":119,"type":120},"2026-08-25","ACTUAL",{"date":122,"type":105},"2026-10",{"date":124,"type":105},"2030-10",{"name":5,"class":6},1]