Depression study: Visbiome
Official title Probiotic Administration for Adolescent Depression
ClinicalTrials.gov ID: NCT06898788
What this study is testing
What is Visbiome?
Visbiome is an investigational oral probiotic powder being studied to see if it helps with depression in young people.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether taking the probiotic Visbiome can change the brain and gut bacteria in people with depression.
- Who it's for
- You may be able to join if you are 15 to 24 years old and have depression.
- What's involved
- You will take a probiotic capsule or a pretend capsule that has no medicine. You will have visits to give samples and answer questions.
- Time commitment
- The study lasts several weeks and includes a few visits to the clinic for check‑ins.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 24
You may be able to join if
- 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...
- Participants must be under the care of a primary care clinician and/or mental health professional
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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).
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.