Probiotics to Prevent Relapse After Hospitalization for Mania

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Bipolar Disorder Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Probiotic Supplement

Intervention Type DIETARY_SUPPLEMENT

Probiotic Supplement 1 tablet by mouth daily

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.

Group Type PLACEBO_COMPARATOR

Inert Compound

Intervention Type DIETARY_SUPPLEMENT

Probiotic identical placebo 1 tablet by mouth daily

Interventions

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Probiotic Supplement

Probiotic Supplement 1 tablet by mouth daily

Intervention Type DIETARY_SUPPLEMENT

Inert Compound

Probiotic identical placebo 1 tablet by mouth daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Probio-Tec

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No