A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania
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|ClinicalTrials.gov Identifier: NCT03383874|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mania (Neurotic)||Combination Product: Probio-Tec BG-VCap-6.5 Other: Placebo||Phase 2|
Primary Aim 1. To determine if adjunctive probiotic administration can reduce relapse for participants first hospitalized for mania. Hypothesis: Participants receiving adjunctive probiotic microorganisms vs. adjunctive placebo will have a lower rate of relapse as defined by a re-hospitalization (e.g., admission to an inpatient unit) during the 24 week study period.
Secondary Outcomes. The number of new mood episodes, the severity of psychiatric symptoms, and changes in cognitive scores over the 24 week study period will be evaluated.
Exploratory Aim 1. To study the effect of probiotic therapy in lowering the levels of inflammatory markers following an acute episode of mania. Hypothesis: Participants receiving adjunctive probiotic microorganisms vs. adjunctive placebo will have reduced levels of antibodies to casein, gliadin, and the NMDA receptor, and reduced levels of C-Reactive protein and the cytokine TNF alpha following 24 weeks of probiotic therapy.
Exploratory Aim 2. To evaluate changes in the gut microbiota following probiotic administration. Hypothesis: Probiotic administration will enrich the gut microbiota of participants with the given microorganisms and these changes may correlate to changes in the peripheral inflammatory markers being measured.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania|
|Actual Study Start Date :||September 6, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||March 2022|
Placebo Comparator: Placebo
Participants will receive capsules containing placebo for 24-weeks.
This placebo is made almost identically to the Probio-Tec but without active microorganisms.
Experimental: Probiotic-Probio-Tec BG-VCap-6.5
Participants will receive capsules containing approximately 10^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
Combination Product: Probio-Tec BG-VCap-6.5
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.
- Relapse rate [ Time Frame: 24 weeks ]Rate of relapse as defined by a re-hospitalization (e.g., admission to an inpatient unit)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383874
|Contact: Alexandra Kulikova, M.S.||email@example.com|
|United States, Texas|
|Psychoneuroendocrine Research Program||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Salina Shrestha, B.S. 214-645-6957 firstname.lastname@example.org|
|Principal Investigator:||Sherwood Brown, MD, PhD||UT Southwestern Medical Center|