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.
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.
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)
Parallel
Probiotic
Dietary supplementParticipants will be instructed to take one capsule once daily in the morning with a meal and water.
Placebo
Dietary supplementParticipants 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).
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).
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.
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.
VIRDIS: heart rate variability
Heart rate variability is measured during the VIRDIS assessment (using a wearable physiological monitoring device). HRV is derived from the variation in time between consecutive heartbeats (interbeat intervals).
VIRDIS: galvanic skin response
Skin conductance (electrodermal activity) measured during the VIRDIS assessment. Outcomes include tonic and phasic skin conductance measures reported in microsiemens (µS).
VIRDIS: pupil dilation
Pupil dilation is measured during the VIRDIS assessment using integrated eye-tracking technology. The outcome is reported as change in pupil diameter (mm).
VIRDIS: gaze velocity
Eye-tracking technology integrated into the VIRDIS assessment records gaze behavior during the virtual reality scenarios. This outcome is reported as the mean gaze velocity (°/s), i.e., average angular velocity of eye movements recorded throughout the virtual reality assessment. Unit of measure: degrees/second (°/s).
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