This trial is active, not recruiting.

Conditions bipolar disorder, schizoaffective disorder
Treatments probiotic supplement, inert compound
Sponsor Sheppard Pratt Health System
Collaborator Stanley Medical Research Institute
Start date November 2012
End date December 2016
Trial size 66 participants
Trial identifier NCT01731171, SMRI/SPHS: 2012/1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
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.
probiotic supplement Probio-Tec
Probiotic Supplement 1 tablet by mouth daily
(Placebo Comparator)
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.
inert compound
Probiotic identical placebo 1 tablet by mouth daily

Primary Outcomes

Time to relapse
time frame: Weeks 1 - 24 of study participation

Secondary Outcomes

New mood episode
time frame: Weeks 1 - 24 of study participation

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
Principal investigator Faith Dickerson, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Sheppard Pratt Health System.