Probiotics to Prevent Relapse After Hospitalization for Mania

Sheppard Pratt Health System

Status: Completed

Conditions: Bipolar Disorder; Schizoaffective Disorder

Treatments: Dietary Supplement: Probiotic Supplement; Dietary Supplement: Inert Compound

Study type: Interventional

Funder types: Other

Identifiers

NCT01731171

SMRI/SPHS: 2012/1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

Probiotic Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic Supplement

Inert Compound

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Inert Compound