Probiotics to Prevent Relapse After Hospitalization for Mania

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Disorder, Schizoaffective Disorder

Intervention / Treatment
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* Dietary Supplement: Probiotic Supplement
* Dietary Supplement: Inert Compound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Supplement<br>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<br>* Probiotic Supplement 1 tablet by mouth daily<br>* Other names: Probio-Tec;|
| Placebo Comparator: Inert Compound<br>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<br>* Probiotic identical placebo 1 tablet by mouth daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Rehospitalization | The primary outcome was the time to first psychiatric inpatient rehospitalization. | Weeks 0 - 24 of study participation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mania, manic episode, mixed episode, bipolar disorder, schizoaffective disorder, probiotics, probiotic supplement, relapse prevention, new mood episode, re-hospitalization