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NCT Number: NCT07728253

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major IBNI617 Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Live biotherapeutic product

Other

IBNI617 PO BID

Placebo

Other

Placebo PO BID

Primary outcomes

  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.

    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.

Secondary outcomes

  1. 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.

  2. Number and percentage of participants experiencing at least one Adverse Event(AE).

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Huafang LI

CONTACT

[email protected]

+86 18017311256

Shen HE

CONTACT

[email protected]

+86 18817314682

Sponsors and collaborators

Lead sponsor

IBIOME BIOTECHNOLOGY CO., LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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