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NCT03349528 · ClinicalTrials.gov registry record · Phase 2

Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

A Phase 2 study, sponsored by Sheppard Pratt Health System.

Active
Registry status
Phase 2
Development phase
80
Enrollment target

NCT03349528: Active Phase 2 study, sponsored by Sheppard Pratt Health System.

NCT03349528 is a Phase 2 study that is active but no longer recruiting, run by Sheppard Pratt Health System. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03349528, a Phase 2 study, is active but no longer recruiting, sponsored by Sheppard Pratt Health System.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target

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.

Primary Outcome

Time to relapse defined as time until psychiatric rehospitalization during the study period

Interventions

  • BIOLOGICAL Inert Compound
  • BIOLOGICAL Probiotic Supplement

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2018-12-11
Est. Completion 2027-12
Phase Phase 2
Sheppard Pratt Health System

10 total trials

What the registry record for NCT03349528 still lists

NCT03349528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Inert Compound is the first listed.

NCT03349528 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03349528 about?

NCT03349528 is a clinical study titled "Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression". 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.

What is the current status of trial NCT03349528?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2018-12-11. Estimated completion is 2027-12.

What interventions are being tested in trial NCT03349528?

The interventions under investigation include: Inert Compound (BIOLOGICAL), Probiotic Supplement (BIOLOGICAL).

Who is sponsoring clinical trial NCT03349528?

This trial is sponsored by Sheppard Pratt Health System, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03349528's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03349528, the US trial registry maintained by the National Library of Medicine. NCT03349528 (small enrollment · none site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.