Probiotic IBNI617 Tested for Moderate to Severe Depression
Tests probiotic capsules IBNI617 against placebo in adults with depression.
Plain-language title generated from the registry record
Registry title: Probiotic IBNI617 for Moderate to Severe Depression
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07728253, who can take part
Where in China
- Shanghai Mental Health CenterShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IBIOME BIOTECHNOLOGY CO., LTD
- Trial code
- NCT07728253
- Record updated
- 30 July 2026
- Original description
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).Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial on the Efficacy and Safety of Probiotic IBNI617 Enteric-Coated Capsules in Patients With 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.
Inclusion: Meets DSM-5 criteria for a single episode or recurrent episode; HAM-D-17 ≥ 22, total score of HAM-D-17 items 4, 5, and 6 ≥ 3; MADRS ≥ 20, CGI-S ≥ 4; Absence of antidepressant medication use or discontinuation of antidepressant medication prior to screening.
Exclusion: Currently use insomnia medication, excluding non-benzodiazepine drugs taken consistently for 4 weeks; With medical history or surgical history that may affect probiotic colonization; Treatment-resistant depression; Suicide attempt or suicide behavior within the past 6 months; Used antibiotics within the past 2 weeks.