Probiotic Administration for Adolescent Depression

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06898788
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Jun 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
77 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Probiotic
    Visbiome 450 billion CFU (sachet) twice daily
  • Placebo Comparator: Placebo twice daily
    Placebo (maltose sachet) twice daily

Primary Outcome Measure

Left hippocampus-precuneus resting state functional connectivity [ Time Frame: Baseline and week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94158
Cherry Leung, PhD, RN
415-502-0955

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