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Not yet recruiting NCT07751614

Probiotic Research for Mental Health in Adult Volunteers

No phase Interventional Healthy Adult Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic, Placebo.
Who it may be relevant to
Registry conditions: Healthy Adult Participants. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Placebo-Controlled Pilot Study Evaluating a Probiotic Intervention for Mental Health

Overview

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.

Interventions

  • Dietary supplement Probiotic
    Participants will be instructed to take one capsule once daily in the morning with a meal and water.
  • Dietary supplement Placebo
    Participants will be instructed to take one capsule once daily in the morning with a meal and water.

Primary outcome measures

  • VIRDIS: Rating of unpleasantness in a virtual reality social scenario [Time frame: This outcome is assessed only at treatment completion (at week 4).]
Secondary outcome measures (3)
  • VIRDIS: a composite score of ratings of unpleasantness across all virtual reality scenarios [Time frame: This outcome is assessed only at treatment completion (at week 4)]
  • VIRDIS: heart rate [Time frame: This outcome is assessed only at treatment completion (at week 4).]
  • Short Form 36 - Energy/Vitality subscale [Time frame: Change from baseline to treatment completion (at week 4)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07751614 · H-25096887

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗