Sheppard Pratt Health System
Baltimore, Maryland, 21285, United States
NCT Number: NCT01731171
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21285, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotic Supplement 1 tablet by mouth daily
Other names: Probio-Tec
Probiotic identical placebo 1 tablet by mouth daily
Time frame: Weeks 0 - 24 of study participation
The primary outcome was the time to first psychiatric inpatient rehospitalization.
Time frame: Weeks 0 - 24 of study participation
This is a count of the participants who had at least one rehospitalization during the study period.
Time frame: Weeks 0 - 24 of study participation
This is a count of the number of rehospitalizations in each group during the study period.
Time frame: Weeks 0 - 24 of study participation
This is the mean number of days rehospitalized for participants in each group during the study period.
Sheppard Pratt Health System
Other
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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