Clinical Trial: Probiotic IBNI617 for Moderate to Severe Depression: A Randomized Controlled Trial

U.S., July 28 -- ClinicalTrials.gov registry received information related to the study (NCT07728253) titled 'Probiotic IBNI617 for Moderate to Severe Depression: A Randomized Controlled Trial' on July 22.

Brief Summary: IBNI617 is a live biotherapeutic product(LBP). This is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial to evaluate the efficacy and safety of IBNI617 in adult patients with major depressive disorder (MDD).

Eligible participants will be randomized in a 1:1 ratio to receive either IBNI617 or matched placebo twice daily for 8 weeks.

The primary objective is to assess the efficacy of IBNI617 compared with placebo, as measured by the change from baseline in HAM-D-17 total score at Week 8....