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NCT03383874 · ClinicalTrials.gov registry record · Phase 3
A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
NCT03383874: Completed Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
NCT03383874 is a Phase 3 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 67 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03383874, a Phase 3 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 67 participants
- Enrollment target
Study Summary
This will be a 24-week, randomized, double-blind, placebo-controlled trial of adjunctive probiotic therapy in 66 persons hospitalized with a manic or mixed episode. The active study compound will consist of capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12. The dose has been selected because it has been used safely in other probiotic trials, was well-tolerated by the participants in two previous trials of individuals with schizophrenia or mania, and was utilized in the original trial on which this replication is based. This dose is higher than that available in most commercially-sold health food supplements. Following hospital discharge, participants will be randomized to receive adjunctive probiotic or placebo for a 24 week period. It is anticipated that of the 66 participants randomized, \~50 (75%) will complete the full 24 weeks of the study. The primary outcome is relapse, defined as re-hospitalization (e.g., admission to an inpatient unit) for psychiatric symptoms following a previous hospital discharge by at least 2 weeks. The occurrence of new mood episodes, the severity of psychiatric symptoms, and any changes in cognitive test scores over the course of the study will also be evaluated. Changes in the levels of inflammatory markers as well as changes in gut microbiota will be evaluated at three time intervals over the course of the study.
Primary Outcome
'Relapse' is defined as re-hospitalization (e.g., admission to an inpatient unit) for psychiatric symptoms following a previous hospital discharge by at least 2 weeks. The rate of relapse was calculated by dividing the number of re-hospitalizations per group (i.e., Placebo, Probiotic) by the number of participants per group so the unit is re-hospitalizations/participant.
Interventions
- OTHER Placebo
- COMBINATION_PRODUCT Probio-Tec BG-VCap-6.5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2024-09-23 |
| Phase | Phase 3 |
What the finished NCT03383874 record still lists
NCT03383874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03383874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03383874 about?
NCT03383874 is a clinical study titled "A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania". This will be a 24-week, randomized, double-blind, placebo-controlled trial of adjunctive probiotic therapy in 66 persons hospitalized with a manic or mixed episode. The active study compound will consist of capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lact...
What is the current status of trial NCT03383874?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2018-09-06. Estimated completion is 2024-09-23.
What interventions are being tested in trial NCT03383874?
The interventions under investigation include: Placebo (OTHER), Probio-Tec BG-VCap-6.5 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03383874?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03383874's enrollment target sits among peer trials
67 1796th of 2000 higher than 204 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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