NCT07728253Not yet recruiting
Probiotic IBNI617 for Moderate to Severe Depression
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
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- Aug 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- IBIOME BIOTECHNOLOGY CO., LTD
- Diseases
- Depression
- NCT number
- NCT07728253
What you commit to
- Study type: Interventional
- Planned participants: 148
- From Aug 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently use insomnia medication, excluding non-benzodiazepine drugs taken consistently for 4 weeks;
- With medical history or surgical history that may affect probiotic colonization.
Other
- Treatment-resistant depression;
- Suicide attempt or suicide behavior within the past 6 months;
- Used antibiotics within the past 2 weeks;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.