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NCT07751614
Probiotic Research for Mental Health in Adult Volunteers
Conditions: Healthy Adult Participants
Sex: All
Ages: 18 Years – 30 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 18-30 years of age
* Native-level Danish language skills
* No current psychiatric illness, confirmed with the Presence State Examination (PSE) and the Standardized Assessment of Personality (SAPAS)
* 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/ADD), 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.
Exclusion Criteria:
* Recent use of probiotics (within the past 4 weeks)
* Use of antibiotics within the past 3 months
* Smoking, chewable tobacco, vaping, or use of other nicotine products
* Neurological disorders (including dementia)
* Use of psychotropic medication within the previous 6 months, including:
* Anxiolytics
* Antidepressants
* Antipsychotics
* Anticonvulsants
* Centrally acting corticosteroids
* Opioid pain relievers
* Hypnotics
* Prescribed sleep medications or herbal sleep aids (e.g., valerian)
* Dyslexia
* Severe physical illness, including:
* Cardiovascular disease
* Diabetes
* Gastrointestinal pathology (e.g., colon cancer, colitis, Crohn's disease)
* Gynecological pathology (e.g., endometriosis)
* Urologic pathology (e.g., prostate cancer)
* Severely immunocompromised status, including:
* HIV positive
* Being a transplant recipient
* Use of anti-rejection medication
* Use of steroids for more than 30 days
* Chemotherapy or radiotherapy within the last year
* Current alcohol or substance abuse disorder
* Previous severe head trauma
* History of epilepsy
* Pregnancy or breastfeeding
* Known allergy to any component of the test product
* 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
* Significant change in dietary habits within the previous 4 weeks (e.g., starting a fibre-enriched diet)
* Planned major changes in diet or exercise habits during the study period
* Current pregnancy
Source: ClinicalTrials.gov (NCT07751614). StuddyBuddy aggregates publicly available trial information.