Major Depressive Disorder (MDD)NCT07728253
Probiotic IBNI617 for Moderate to Severe Depression
A study testing Live biotherapeutic product in people with Major Depressive Disorder (MDD) and IBNI617, run by IBIOME BIOTECHNOLOGY CO., LTD at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD), IBNI617
- What is being tested?
- Live biotherapeutic product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai
Shen HE, +86 18817314682, shenhe0204@126.com
About this study
Official 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
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.
- Conditions
- Major Depressive Disorder (MDD), IBNI617
- Being tested
- Live biotherapeutic product, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live biotherapeutic productOther
IBNI617 PO BID
PlaceboOther
Placebo PO BID
| Study group | Role | What they receive |
|---|---|---|
| IBNI617 | Experimental | IBNI617 BID for 8 weeks Receives: Other: Live biotherapeutic product |
| Placebo | Placebo comparator | Placebo BID for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 8 weeks
Secondary outcomes (2)
Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8
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.
Measured: 8 weeks
Number and percentage of participants experiencing at least one Adverse Event(AE).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBIOME BIOTECHNOLOGY CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728253
- Sponsor's protocol ID
- HW-617-02
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07728253
- Acronym / sponsor ID
- HW-617-02
- Conditions
- Major Depressive Disorder (MDD), IBNI617
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- IBIOME BIOTECHNOLOGY CO., LTDIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBNI617 | Experimental | Other: Live biotherapeutic productIBNI617 BID for 8 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo BID for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live biotherapeutic productIBNI617 PO BID | Other | IBNI617 |
| PlaceboPlacebo PO BID | Other | Placebo |
Primary outcome
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.
2 secondary outcomes
Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8
Time frame: 8 weeks
Number and percentage of participants experiencing at least one Adverse Event(AE).
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live biotherapeutic product in people with Major Depressive Disorder (MDD) and IBNI617, run by IBIOME BIOTECHNOLOGY CO., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huafang LI (+86 18017311256, hlhl_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.