DepressionEarly Phase 1PADNCT06898788
Probiotic Administration for Adolescent Depression
A Early Phase 1 study testing Visbiome in people with Depression, run by University of California, San Francisco at 1 site in United States.
Trial summary
This double-blind, placebo-controlled clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Depression
- What is being tested?
- Visbiome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to Dec 2026
- Phase
- Early Phase 1
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female and male participants 15 to 24 years of age
- Fluency in English
- Access to smartphone, tablet, or computer, on which program "Zoom" can be run for remote visits
- Diagnosed with a primary DSM-5 clinical depressive disorder (Major Depressive Disorder, Persistent Depressive Disorder, or Other Specified Depressive Disorder). The DSM-5 clinical depressive disorder will be confirmed by the Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Computerized Version (K-SADS-COMP)47 to participants <18 years and the Structured Clinic Interview for DSM-5 (SCID-V) to participants ≥18 years.
- Participants must be under the care of a primary care clinician and/or mental health professional
- Currently on SSRI for at least 8 weeks
- BDI-II score greater than 13
Who cannot join
- Current diagnosis of other DSM-5 mental health disorders except for anxiety disorders and ADHD as long as depressive disorder is the primary diagnosis
- Current medically-treated with stimulant medication for ADHD unless subject is on stable dosage of stimulant medication and there are no plans to change the stimulant medication or dosage for at least 8 weeks.
- Current diagnosis of any Axis II personality disorder(s) as assessed by the K-SADS-COMP or SCID-V.
- Oral probiotic use 1 month prior to phone screening
- Oral or IV antibiotic use 1 month prior to phone screening
- Fermented foods (e.g., yogurt, kombucha) 1 month prior to phone screening
Show all 18Show fewer
- Oral antioxidant or omega 3 supplements <6 weeks prior to phone screening
- Current alcohol intake greater than 2 drinks per week
- Smoking cigarettes (>5 during last 6 months) or tobacco (pipe or hookah #1 time during last month)
- Any plans to make significant change in diet and lifestyle
- Immunocompromised patients
- Allergies to milk, soy, or yeast
- Tanner Stage <3
- Current active suicidal ideation that requires psychiatric hospitalization or suicidal ideation with plan or intent to attempt suicide as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Prior suicide attempt within past 6 months that required hospitalization and/or visit to the Emergency Department
- History of failure to clinically respond to 2 or more adequate trials of 2 different first-line SSRI antidepressant medications
- Any contraindication to MRI (e.g., braces)
- Pregnancy or any plans to become pregnant during the study is an exclusion criterion for entrance into the study. Women of reproductive capability will be asked about pregnancy or plans to become pregnant. Women of reproductive capability will be asked to employ at least one of the following allowable contraception methods until they complete their second MRI: birth control implant, birth control shot, birth control patch, birth control pill, condom, internal condom, birth control sponge, cervical cap, spermicide, fertility awareness (calendar method), outercourse and abstinence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSF
San Francisco, California, 94158
Cherry Leung, PhD, RN, 415-502-0955, cherry.leung@ucsf.edu
About this study
This double-blind, placebo-controlled clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age.
Read the detailed description
This trial will evaluate the effects of Visbiome 450 billion CFU taken orally twice daily on the biological signature of left hippocampal (HP) resting-state functional connectivity (RSFC) and gut microbiome composition in individuals between the ages of 15 and 24 years.This study will assess the safety and tolerability of Visbiome at this dosage.
Participants will be enrolled in the study for a total of eight weeks and randomized to the probiotic or placebo group. Follow-up assessments will take place every two weeks and will be conducted either through Zoom video visits or in person. The primary outcomes of the study include the effects of the intervention on neural connectivity and gut microbiome composition. Neural connectivity will be assessed by measuring the left HP RSFC using functional magnetic resonance imaging (fMRI). Gut microbiome composition will be evaluated by assessing beta diversity through stool samples collected at baseline and post-intervention.
The safety and tolerability of the intervention will be carefully monitored throughout the study. Adverse events will be systematically collected at each visit, graded for severity, and evaluated for their relationship to the probiotic intervention. Tolerability will be assessed using the Generic Assessment of Side Effects - Probiotics (GASE-P). This measure will be administered at baseline and every two weeks throughout the study period.
- Conditions
- Depression
- Being tested
- Visbiome, Placebo
- Keywords
- probiotics, adolescents, gut microbiome, gut microbiota, fMRI, brain MRI, depression, depressive disorders, youth, young adults
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisbiomeDrug
Visbiome® is an oral multi-strain probiotic which contains 8 strains: Lactobacillus (L.) paracasei, L. planatrum, L. acidophilus, L. helveticus, Bifidobacterium (B.) longum, B. infantis, B. breve, and Streptococcus (S.) thermophilus.
Participants will be instructed to consume the powder mixed in water.
PlaceboDrug
Participants will be instructed to consume the powder mixed in water (same instructions as the probiotic group).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Visbiome 450 billion CFU (sachet) twice daily Receives: Drug: Visbiome |
| Placebo twice daily | Placebo comparator | Placebo (maltose sachet) twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left hippocampus-precuneus resting state functional connectivity
Measured with fMRI.
Measured: Baseline and week 8
Beta diversity
Gut microbiome measurement
Measured: Baseline and week 8
Generic Assessment of Side Effects - Probiotics (GASE-P)
Assesses for tolerability, safety, and adverse events.
Measured: Every 2 weeks from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start15 May 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), 2-arm, single-center, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Cherry Leung, PhD, RN, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898788
- Sponsor's protocol ID
- 24-41760
- Other IDs
- R61AT012028
- Acronym
- PAD
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this research will be made available via publication in scientific and medical journals as well as through scientific and medical meetings/conferences where our results will be reported. Publication of data will occur during the time course of this project consistent with normal scientific practices and consistent with NIH policies. Although the final dataset will be stripped of identifiers prior to release for sharing, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. The investigators will thus make the data and associated documentation available to users only under a data-sharing agreement that provides for the following: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Publications
Ouwehand AC, Invernici MM, Furlaneto FAC, Messora MR. Effectiveness of Multistrain Versus Single-strain Probiotics: Current Status and Recommendations for the Future. J Clin Gastroenterol. 2018 Nov/Dec;52 Suppl 1, Proceedings from the 9th Probiotics, Prebiotics and New Foods, Nutraceuticals and Botanicals for Nutrition & Human and Microbiota Health Meeting, held in Rome, Italy from September 10 to 12, 2017:S35-S40. doi: 10.1097/MCG.0000000000001052.
PubMed 29734210Liu RT, Walsh RFL, Sheehan AE. Prebiotics and probiotics for depression and anxiety: A systematic review and meta-analysis of controlled clinical trials. Neurosci Biobehav Rev. 2019 Jul;102:13-23. doi: 10.1016/j.neubiorev.2019.03.023. Epub 2019 Apr 17.
PubMed 31004628
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Administration for Adolescent Depression
- ClinicalTrials.gov ID
- NCT06898788
- Acronym / sponsor ID
- PAD / 24-41760
- Conditions
- Depression
- Keywords
- probiotics, adolescents, gut microbiome, gut microbiota, fMRI, brain MRI, depression, depressive disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 15 May 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2025 (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 double-blind, placebo-controlled clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age.
Detailed description
This trial will evaluate the effects of Visbiome 450 billion CFU taken orally twice daily on the biological signature of left hippocampal (HP) resting-state functional connectivity (RSFC) and gut microbiome composition in individuals between the ages of 15 and 24 years.This study will assess the safety and tolerability of Visbiome at this dosage.
Participants will be enrolled in the study for a total of eight weeks and randomized to the probiotic or placebo group. Follow-up assessments will take place every two weeks and will be conducted either through Zoom video visits or in person. The primary outcomes of the study include the effects of the intervention on neural connectivity and gut microbiome composition. Neural connectivity will be assessed by measuring the left HP RSFC using functional magnetic resonance imaging (fMRI). Gut microbiome composition will be evaluated by assessing beta diversity through stool samples collected at baseline and post-intervention.
The safety and tolerability of the intervention will be carefully monitored throughout the study. Adverse events will be systematically collected at each visit, graded for severity, and evaluated for their relationship to the probiotic intervention. Tolerability will be assessed using the Generic Assessment of Side Effects - Probiotics (GASE-P). This measure will be administered at baseline and every two weeks throughout the study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1), 2-arm, single-center, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Drug: VisbiomeVisbiome 450 billion CFU (sachet) twice daily |
| Placebo twice daily | Placebo comparator | Drug: PlaceboPlacebo (maltose sachet) twice daily |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Female and male participants 15 to 24 years of age
- Fluency in English
- Access to smartphone, tablet, or computer, on which program "Zoom" can be run for remote visits
- Diagnosed with a primary DSM-5 clinical depressive disorder (Major Depressive Disorder, Persistent Depressive Disorder, or Other Specified Depressive Disorder). The DSM-5 clinical depressive disorder will be confirmed by the Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Computerized Version (K-SADS-COMP)47 to participants <18 years and the Structured Clinic Interview for DSM-5 (SCID-V) to participants ≥18 years.
- Participants must be under the care of a primary care clinician and/or mental health professional
Key exclusion criteria (18 listed)
- Current diagnosis of other DSM-5 mental health disorders except for anxiety disorders and ADHD as long as depressive disorder is the primary diagnosis
- Current medically-treated with stimulant medication for ADHD unless subject is on stable dosage of stimulant medication and there are no plans to change the stimulant medication or dosage for at least 8 weeks.
- Current diagnosis of any Axis II personality disorder(s) as assessed by the K-SADS-COMP or SCID-V.
- Oral probiotic use 1 month prior to phone screening
- Oral or IV antibiotic use 1 month prior to phone screening
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 |
|---|---|---|
| VisbiomeVisbiome® is an oral multi-strain probiotic which contains 8 strains: Lactobacillus (L.) paracasei, L. planatrum, L. acidophilus, L. helveticus, Bifidobacterium (B.) longum, B. infantis, B. breve, and Streptococcus (S.) thermophilus. Participants will be instructed to consume the powder mixed in water. | Drug | Probiotic |
| PlaceboParticipants will be instructed to consume the powder mixed in water (same instructions as the probiotic group). | Drug | Placebo twice daily |
Primary outcome
Left hippocampus-precuneus resting state functional connectivity
Time frame: Baseline and week 8
Measured with fMRI.
Beta diversity
Time frame: Baseline and week 8
Gut microbiome measurement
Generic Assessment of Side Effects - Probiotics (GASE-P)
Time frame: Every 2 weeks from baseline to week 8
Assesses for tolerability, safety, and adverse events.
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 14 Jul 2026.
- Background: PubMed 29734210Ouwehand AC, Invernici MM, Furlaneto FAC, Messora MR. Effectiveness of Multistrain Versus Single-strain Probiotics: Current Status and Recommendations for the Future. J Clin Gastroenterol. 2018 Nov/Dec;52 Suppl 1, Proceedings from the 9th Probiotics, Prebiotics and New Foods, Nutraceuticals and Botanicals for Nutrition & Human and Microbiota Health Meeting, held in Rome, Italy from September 10 to 12, 2017:S35-S40. doi: 10.1097/MCG.0000000000001052.
- Background: PubMed 31004628Liu RT, Walsh RFL, Sheehan AE. Prebiotics and probiotics for depression and anxiety: A systematic review and meta-analysis of controlled clinical trials. Neurosci Biobehav Rev. 2019 Jul;102:13-23. doi: 10.1016/j.neubiorev.2019.03.023. Epub 2019 Apr 17.
- Individual participant dataSharing planned: Yes. The results of this research will be made available via publication in scientific and medical journals as well as through scientific and medical meetings/conferences where our results will be reported. Publication of data will occur during the time course of this project consistent with normal scientific practices and consistent with NIH policies. Although the final dataset will be stripped of identifiers prior to release for sharing, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. The investigators will thus make the data and associated documentation available to users only under a data-sharing agreement that provides for the following: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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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.
Cherry Leung, PhD, RN principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Visbiome in people with Depression, run by University of California, San Francisco at 1 site in United States.
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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cherry Leung, PhD, RN ((415) 502-0955, cherry.leung@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left hippocampus-precuneus resting state functional connectivity (time frame: Baseline and week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06898788, which also lists 2 linked publications.
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 14 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.