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Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

NCT03349528 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-07

No results posted yet for this study

Summary

The purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.

Conditions

Interventions

BIOLOGICAL

Probiotic Supplement

Probiotic supplement 1 tablet by mouth daily

BIOLOGICAL

Inert Compound

Probiotic identical placebo 1 tablet by mouth daily

Sponsors & Collaborators

  • Sheppard Pratt Health System

    lead OTHER

Principal Investigators

  • Faith Dickerson, PhD, MPH · Sheppart Pratt Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349528 on ClinicalTrials.gov