Probiotics to Prevent Relapse After Hospitalization for Mania
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|