Probiotic IBNI617 for Moderate to Severe Depression

July 29, 2026 updated by: IBIOME BIOTECHNOLOGY CO., LTD

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huafang LI
  • Phone Number: +86 18017311256
  • Email: hlhl_5@163.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBNI617
IBNI617 BID for 8 weeks
Other: Live biotherapeutic product
IBNI617 PO BID
Placebo Comparator: Placebo
Placebo BID for 8 weeks
Other: Placebo
Placebo PO BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 8 weeks
The HAM-D-17 is a 17-item, clinician-rated scale that assesses depressive symptoms. Each item is rated on a scale of 0-2 or 0-4. The total score can range from 0-52. Higher HAM-D-17 scores indicate more severe depression.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of participants experiencing at least one Adverse Event(AE).
Time Frame: 12 weeks
12 weeks
Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8
Time Frame: 8 weeks
The MADRS is a 10-item, clinician-rated scale that assesses depressive symptoms. Each item is rated on a scale of 0-6. The total score can range from 0-60. Higher MADRS scores indicate more severe depression.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IBIOME BIOTECHNOLOGY CO., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HW-617-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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