Probiotic IBNI617 for Moderate to Severe Depression

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.

NCT Number	NCT07728253
Lead Sponsor	IBIOME BIOTECHNOLOGY CO., LTD
Conditions	Major Depressive Disorder (MDD), IBNI617
Enrollment	148 participants
Start Date	2026-08
Primary Completion	2027-12 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-07-30