Probiotic Research for Mental Health in Adult Volunteers

NCT07751614 | Not Yet Recruiting DMC

• 1 other identifier: H-25096887
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Gut microbiome; Mental well-being; Probiotic; Healthy adults

Outcome Measures

Primary Outcomes (1)

• 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).

  This outcome is assessed only at treatment completion (at week 4).

Secondary Outcomes (3)

• VIRDIS: a composite score of ratings of unpleasantness across all virtual reality scenarios

  This outcome is assessed only at treatment completion (at week 4)

• VIRDIS: heart rate

  This outcome is assessed only at treatment completion (at week 4).

• Short Form 36 - Energy/Vitality subscale

  Change from baseline to treatment completion (at week 4)

Other Outcomes (23)

• VIRDIS: heart rate variability

  This outcome is assessed only at treatment completion (at week 4).

• VIRDIS: galvanic skin response

  This outcome is assessed only at treatment completion (at week 4).

• VIRDIS: pupil dilation

  This outcome is assessed only at treatment completion (at week 4).

Study Arms (2)

Probiotic

EXPERIMENTAL

Daily oral supplementation of probiotic for 4 weeks

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Daily oral supplementation of placebo for 4 weeks

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants will be instructed to take one capsule once daily in the morning with a meal and water.

Probiotic

Placebo DIETARY_SUPPLEMENT

Participants will be instructed to take one capsule once daily in the morning with a meal and water.

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kamilla Woznica Miskowiak, Professor, DMSc, DPhil

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamilla Woznica Miskowiak, Professor, DMSc, DPhil

CONTACT

+4522771617; kamilla.woznica.miskowiak@regionh.dk

Andreas Elleby Jespersen, PhD

CONTACT

+4524979364; andreas.elleby.jespersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc, DPhil, Head of the NEAD Centre

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 7, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Six months after publication