At a glance
ClinicalIndex Comparison Record- ✓Recently hospitalized (within last 3 weeks) for symptoms of mania
- ✓Primary diagnosis 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)
- ✓Capable of providing written informed consent
- ✓Proficient in English language
- ✕Substance- or medically-induced mania at time of assessment
- ✕HIV infection or other immunodeficiency condition (including active cancer chemotherapy)
- ✕Serious neurological or brain condition affecting cognitive function (epilepsy, serious head injury, concussion with loss of consciousness, brain tumor, or other neurological disorder)
- ✕Poorly controlled comorbid medical condition
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania
In Brief
A Phase 3 clinical trial evaluating Probio-Tec BG-VCap-6.5 and Placebo for Mania (Neurotic). Completed, enrolled 67 participants across 1 site.
Detailed Summary
This will be a 24-week, randomized, double-blind, placebo-controlled trial of adjunctive probiotic therapy in 66 persons hospitalized with a manic or mixed episode. The active study compound will consist of capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12. The dose has been selected because it has been used safely in other probiotic trials, was well-tolerated by the participants in two previous trials of individuals with schizophrenia or mania, and was utilized in the original trial on which this replication is based. This dose is higher than that available in most commercially-sold health food supplements. Following hospital discharge, participants will be randomized to receive adjunctive probiotic or placebo for a 24 week period. It is anticipated that of the 66 participants randomized, \~50 (75%) will complete the full 24 weeks of the study. The primary outcome is relapse, defined as re-hospitalization (e.g., admission to an inpatient unit) for psychiatric symptoms following a previous hospital discharge by at least 2 weeks. The occurrence of new mood episodes, the severity of psychiatric symptoms, and any changes in cognitive test scores over the course of the study will also be evaluated. Changes in the levels of inflammatory markers as well as changes in gut microbiota will be evaluated at three time intervals over the course of the study.
Study Details
Timeline
Interventions
The product under investigation is a probiotic containing two microorganisms (Lactobacillus rhamnosus, LGG® and Bifidobacterium animalis subsp. lactis, BB-12®, referred to as LGG® and BB-12®, respectively) and is offered commercially as "Probio-Tec BG-VCap-6.5". This composition is formulated to contain a minimum of 1 billion (1.0 x 10\^9) CFU (Colony Forming Units) per dose (capsule), including equal numbers of the two strains; i.e. 0.5 x 10\^9 CFU of each of LGG® and BB-12® at the time of manufacture. The product will be administered orally.
This placebo is made almost identically to the Probio-Tec but without active microorganisms.