Probiotics to Prevent Relapse After Hospitalization for Mania

Not Applicable

Completed

Interventions: Dietary Supplement: Inert Compound
Dietary Supplement: Probiotic Supplement

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Age 18-65
Capacity for written informed consent
Currently admitted to a Sheppard Pratt inpatient or day hospital for symptoms of mania
Primary Axis I diagnosis (DSM-IV) at time of admission of Bipolar I Disorder (single manic episode, most recent episode manic, or most recent episode mixed) OR Schizoaffective Disorder, Bipolar type (manic or mixed state)
Proficient in the English language
Available to come to Sheppard Pratt Towson for follow-up visits
Participated previously in one of our screening studies

Exclusion Criteria

Diagnosis of mental retardation
Symptoms of mania secondary to a general medical condition
Any clinically significant or unstable medical disorder as determined by the investigators including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition
History of IV drug use
Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last 3 months, or has a positive drug toxicity screen
Participated in any investigational drug trial in the past 30 days
Pregnant or planning to become pregnant during the study period
Receipt of antibiotic medication within the previous 24 hours (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics)
Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care). Of note, we are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as we intend to look at these levels as a predictor of response.

Arm && Interventions

Group	Intervention	Description
Inert Compound	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.
Probiotic Supplement	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.

Primary Outcome Measures

Name	Time	Method
Time to First Rehospitalization	Weeks 0 - 24 of study participation	The primary outcome was the time to first psychiatric inpatient rehospitalization.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Rehospitalized	Weeks 0 - 24 of study participation	This is a count of the participants who had at least one rehospitalization during the study period.
Total Number of Rehospitalizations	Weeks 0 - 24 of study participation	This is a count of the number of rehospitalizations in each group during the study period.
Mean Days Rehospitalized	Weeks 0 - 24 of study participation	This is the mean number of days rehospitalized for participants in each group during the study period.