Probiotic Research for Mental Health in Adult Volunteers
NCT07751614 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-08-07
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.
Conditions
- Healthy Adult Participants
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.
Sponsors & Collaborators
-
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
lead OTHER
Principal Investigators
-
Kamilla Woznica Miskowiak, Professor, DMSc, DPhil · Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
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