Probiotic IBNI617 for Moderate to Severe Depression (NCT07728253) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Probiotic IBNI617 for Moderate to Severe Depression
China148 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Treatment-resistant depression;
* Suicide attempt or suicide behavior within the past 6 months;
* Used antibiotics within the past 2 weeks;
* Currently use insomnia medication, excluding non-benzodiazepine drugs taken consistently for 4 weeks;
* With medical history or surgical history that may affect probiotic colonization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a probiotic called IBNI617 for moderate to severe depression — how does a probiotic approach differ from standard antidepressant medications, and is that something worth considering given my situation?
2The trial isn't recruiting yet — do you have any sense of when it might open, and would waiting for it delay other treatment options I should be starting now?
3The main outcome is measured at 8 weeks using the HAM-D-17 depression scale — is 8 weeks a realistic timeframe to expect meaningful change, and how does that compare to how quickly my current or planned treatment might work?
4Since this trial lists no specific phase, what does that tell us about how much is already known about IBNI617's safety and effectiveness in people with depression like mine?
5Would I still be able to adjust or switch my treatment during the trial if my depression worsened, or would being in a placebo-controlled study limit what you could do to help me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the efficacy of IBNI617 compared with placebo, as measured by the change from baseline in Hamilton Depression Scale (HAM-D-17) total score at Week 8.