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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
60
Participants will be instructed to take one capsule once daily in the morning with a meal and water.
Participants will be instructed to take one capsule once daily in the morning with a meal and water.
VIRDIS: Rating of unpleasantness in a virtual reality social scenario
Participants complete a virtual reality-based assessment (VIRDIS) and rate their level of unpleasantness following exposure to a predefined social scenario. Unpleasantness is assessed on a 5-point scale ranging from 1 (not at all unpleasant) to 5 (very unpleasant).
Time frame: This outcome is assessed only at treatment completion (at week 4).
VIRDIS: a composite score of ratings of unpleasantness across all virtual reality scenarios
This outcome comprises the mean unpleasantness score across all VR scenarios in the VIRDIS test on a scale ranging from 1 (not at all unpleasant) to 5 (very unpleasant).
Time frame: This outcome is assessed only at treatment completion (at week 4)
VIRDIS: heart rate
Heart rate is measured during the VIRDIS assessment (using a wearable physiological monitoring device). Heart rate (pulse) is reported in beats per minute (bpm). Higher scores indicating higher heart rate.
Time frame: This outcome is assessed only at treatment completion (at week 4).
Short Form 36 - Energy/Vitality subscale
The SF-36 questionnaire will be administered in its entirety. The Energy/Vitality subscale (items 23, 27, 29, and 31) is designated as a secondary outcome measure.
Time frame: Change from baseline to treatment completion (at week 4)
Kamilla Woznica Miskowiak, Professor, DMSc, DPhil
CONTACT
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