Probiotic Administration for Adolescent Depression
NCT06898788 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 77
Last updated 2025-06-06
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.
Conditions
Interventions
- DRUG
-
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.
- DRUG
-
Participants will be instructed to consume the powder mixed in water (same instructions as the probiotic group).
Sponsors & Collaborators
-
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Cherry Leung, PhD, RN · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 24 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-15
- Primary Completion
- 2026-08-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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