A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania

PHASE3CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

September 6, 2018

Primary Completion Date

September 23, 2024

Study Completion Date

September 23, 2024

Conditions
Mania (Neurotic)
Interventions
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."

OTHER

Placebo

This placebo is made almost identically to the Probio-Tec but without active microorganisms.

Trial Locations (1)

75235

Psychoneuroendocrine Research Program, Dallas

All Listed Sponsors
lead

University of Texas Southwestern Medical Center

OTHER

NCT03383874 - A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania | Biotech Hunter | Biotech Hunter