Healthy Adult ParticipantsNCT07751614
Probiotic Research for Mental Health in Adult Volunteers
A study testing Probiotic in people with Healthy Adult Participants, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 35Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kamilla Woznica Miskowiak, Professor, DMSc, DPhil contact
About this study
Official title: A Randomized, Placebo-Controlled Pilot Study Evaluating a Probiotic Intervention for Mental Health
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
- Being tested
- Probiotic, Placebo
- Keywords
- Gut microbiome, Mental well-being, Probiotic, Healthy adults
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants will be instructed to take one capsule once daily in the morning with a meal and water.
PlaceboDietary supplement
Participants will be instructed to take one capsule once daily in the morning with a meal and water.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Daily oral supplementation of probiotic for 4 weeks Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Daily oral supplementation of placebo for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 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).
Measured: 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.
Measured: 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.
Measured: Change from baseline to treatment completion (at week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamilla Woznica Miskowiak, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Kamilla Woznica Miskowiak, Professor, DMSc, DPhil, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751614
- Sponsor's protocol ID
- H-25096887
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Although full open access is restricted due to General Data Protection Regulation, anonymised participant data may be shared on resonable request to researchers who provide a methodologically sound proposal, beginning 6 months after publication. Study protocols and statistical analysis plans will also be available. Proposals should be directed to Kamilla.woznica.miskowiak@regionh.dk. to gain access and data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Pilot Study Evaluating a Probiotic Intervention for Mental Health
- ClinicalTrials.gov ID
- NCT07751614
- Acronym / sponsor ID
- H-25096887
- Conditions
- Healthy Adult Participants
- Keywords
- Gut microbiome, Mental well-being, Probiotic, Healthy adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticDaily oral supplementation of probiotic for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily oral supplementation of placebo for 4 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (35 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticParticipants will be instructed to take one capsule once daily in the morning with a meal and water. | Dietary supplement | Probiotic |
| PlaceboParticipants will be instructed to take one capsule once daily in the morning with a meal and water. | Dietary supplement | Placebo |
Primary outcome
VIRDIS: Rating of unpleasantness in a virtual reality social scenario
Time frame: This outcome is assessed only at treatment completion (at week 4).
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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Although full open access is restricted due to General Data Protection Regulation, anonymised participant data may be shared on resonable request to researchers who provide a methodologically sound proposal, beginning 6 months after publication. Study protocols and statistical analysis plans will also be available. Proposals should be directed to Kamilla.woznica.miskowiak@regionh.dk. to gain access and data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kamilla Woznica Miskowiak, Professor, DMSc, DPhil contact
Kamilla Woznica Miskowiak, Professor, DMSc, DPhil principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy Adult Participants, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamilla Woznica Miskowiak, Professor, DMSc, DPhil (+4522771617, kamilla.woznica.miskowiak@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VIRDIS: Rating of unpleasantness in a virtual reality social scenario (time frame: This outcome is assessed only at treatment completion (at week 4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.