[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650757":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":25,"responsibleParty":41,"collaborators":25,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":25,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":25},{"fullName":5,"class":6},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic","EXPERIMENTAL","Daily oral supplementation of probiotic for 4 weeks",[13],"Dietary Supplement: Probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Daily oral supplementation of placebo for 4 weeks",[19],"Dietary Supplement: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Participants will be instructed to take one capsule once daily in the morning with a meal and water.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Kamilla Woznica Miskowiak, Professor, DMSc, DPhil","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":25,"email":36},"CONTACT","+4522771617","kamilla.woznica.miskowiak@regionh.dk",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Andreas Elleby Jespersen, PhD","+4524979364","andreas.elleby.jespersen@regionh.dk",{"type":31,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Kamilla Woznica Miskowiak","Professor, DMSc, DPhil, Head of the NEAD Centre","100650757","probiotic-research-for-mental-health-in-adult-volunteers-100650757",false,"NCT07751614","Probiotic Research for Mental Health in Adult Volunteers","A Randomized, Placebo-Controlled Pilot Study Evaluating a Probiotic Intervention for Mental Health","Inclusion Criteria:\n\n* 18-30 years of age\n* Native-level Danish language skills\n* No current psychiatric illness, confirmed with the Presence State Examination (PSE) and the Standardized Assessment of Personality (SAPAS)\n* No previous history of severe psychiatric illness, including bipolar disorder, recurrent unipolar depression, psychosis spectrum disorders, personality disorders, autism spectrum disorders, or attention deficit (hyperactivity) disorder (ADHD\u002FADD), confirmed with PSE and SAPAS. Participants may still be included if they have a history of a single depressive episode, or have experienced symptoms of anxiety, stress, or burnout more than 6 months ago.\n\nExclusion Criteria:\n\n* Recent use of probiotics (within the past 4 weeks)\n* Use of antibiotics within the past 3 months\n* Smoking, chewable tobacco, vaping, or use of other nicotine products\n* Neurological disorders (including dementia)\n* Use of psychotropic medication within the previous 6 months, including:\n* Anxiolytics\n* Antidepressants\n* Antipsychotics\n* Anticonvulsants\n* Centrally acting corticosteroids\n* Opioid pain relievers\n* Hypnotics\n* Prescribed sleep medications or herbal sleep aids (e.g., valerian)\n* Dyslexia\n* Severe physical illness, including:\n* Cardiovascular disease\n* Diabetes\n* Gastrointestinal pathology (e.g., colon cancer, colitis, Crohn's disease)\n* Gynecological pathology (e.g., endometriosis)\n* Urologic pathology (e.g., prostate cancer)\n* Severely immunocompromised status, including:\n* HIV positive\n* Being a transplant recipient\n* Use of anti-rejection medication\n* Use of steroids for more than 30 days\n* Chemotherapy or radiotherapy within the last year\n* Current alcohol or substance abuse disorder\n* Previous severe head trauma\n* History of epilepsy\n* Pregnancy or breastfeeding\n* Known allergy to any component of the test product\n* Participation in a clinical study with another investigational product within 60 days before screening, or plans to participate in another study during the study period\n* Significant change in dietary habits within the previous 4 weeks (e.g., starting a fibre-enriched diet)\n* Planned major changes in diet or exercise habits during the study period\n* Current pregnancy",true,"ALL","18 Years","30 Years",{"count":56,"type":57},60,"ESTIMATED","INTERVENTIONAL",[60],"NA","This randomized, double-blind, placebo-controlled pilot study will evaluate the effects of four weeks of supplementation with a probiotic on mental health in healthy adults aged 18-30 years. Participants will be randomized to receive either probiotic or placebo and will complete study assessments at baseline and end of intervention, and will complete a range of behavioral, physiological, and questionnaire-based assessments before and after the intervention. The primary objective is to assess the effect on emotional reactivity measured in a virtual reality scenario at the end of the intervention. This exploratory study is intended to generate data to inform future clinical research.",[63],"Healthy Adult Participants",[65,66,9,67],"Gut microbiome","Mental well-being","Healthy adults","NOT_YET_RECRUITING","2026-08-05",{"date":71,"type":72},"2026-08-07","ACTUAL",{"date":74,"type":57},"2026-09-01",{"date":76,"type":57},"2027-03-31",{"name":5,"class":6}]