Probiotics to Prevent Relapse After Hospitalization for Mania
|ClinicalTrials.gov Identifier: NCT01731171|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Schizoaffective Disorder||Dietary Supplement: Probiotic Supplement Dietary Supplement: Inert Compound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Probiotic Supplement
The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.
Dietary Supplement: Probiotic Supplement
Probiotic Supplement 1 tablet by mouth daily
Other Name: Probio-Tec
Placebo Comparator: Inert Compound
The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.
Dietary Supplement: Inert Compound
Probiotic identical placebo 1 tablet by mouth daily
- Time to relapse [ Time Frame: Weeks 1 - 24 of study participation ]Time to relapse is defined as time until rehospitalization during the study period after a minimum of a 3 day interval after discharge from a previous hospital stay.
- New mood episode [ Time Frame: Weeks 1 - 24 of study participation ]New mood episodes are defined by DSM-IV criteria for a manic, mixed, or depressive episode.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731171
|United States, Maryland|
|Sheppard Pratt Health System|
|Baltimore, Maryland, United States, 21285|
|Principal Investigator:||Faith Dickerson, PhD, MPH||Sheppard Pratt Health System|