Probiotic Administration for Adolescent Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotics and the Microbiome: Clinical Intervention Trial for Anxiety and Depression

NCT02035878

Anxiety Depression

UNKNOWN PHASE2

Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms

NCT05564767

Depression, Anxiety

COMPLETED NA

The Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder

NCT05315401

Major Depressive Disorder

WITHDRAWN PHASE2

The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients

NCT02838043

Major Depressive Disorder Depression Depressive Symptoms

COMPLETED PHASE3

Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease

NCT05568498

Parkinson Disease Depression

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized (1:1), 2-arm, single-center, placebo controlled

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants will be randomized into either the Visbiome® or placebo groups through computer-generated randomization at their initial baseline visit, with random block sizes ranging from 2 to 4 and stratification by sex.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic

Visbiome 450 billion CFU (sachet) twice daily

Group Type ACTIVE_COMPARATOR

Visbiome

Intervention Type DRUG

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.

Placebo twice daily

Placebo (maltose sachet) twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be instructed to consume the powder mixed in water (same instructions as the probiotic group).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Visbiome

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.

Intervention Type DRUG

Placebo

Participants will be instructed to consume the powder mixed in water (same instructions as the probiotic group).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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). 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

Exclusion Criteria

* 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. 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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No