NCT01731171

Probiotics to Prevent Relapse After Hospitalization for Mania

A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Sheppard Pratt Health System · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if taking a probiotic supplement versus a placebo will lower rates of relapse and improve the clinical course among participants who have been hospitalized for mania. Relapse and clinical course are measured by time to re-hospitalizations, new mood episodes, and changes in mood-related symptoms.

Conditions

• Bipolar Disorder
• Schizoaffective Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Supplement	Probiotic Supplement 1 tablet by mouth daily
DIETARY_SUPPLEMENT	Inert Compound	Probiotic identical placebo 1 tablet by mouth daily

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-11-21
• Last updated: 2019-01-07
• Results posted: 2019-01-07

Locations

1 site across 1 country: United States