Depressive DisorderNCT07562516
PB-18 Probiotic for Mild to Moderate Depression
A study testing Bifidobacterium in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University.
Trial summary
The goal of this clinical trial is to learn if Bifidobacterium PB-18 can treat mild to moderate depressive disorder in adults aged 18 to 65 years who are not taking antidepressants or other psychotropic medications during the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Bifidobacterium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2026to 30 Apr 2027
- 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
- Outpatient or inpatient participants, aged 18 to 65 years (inclusive), of any sex
- Current episode meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for depressive disorder
- Baseline score on the 17-Item Hamilton Depression Rating Scale is 7 to 24, inclusive
- No concomitant use of antidepressants or other psychotropic medications during the study
- Elementary school education or above, able to understand the study requirements and complete the rating scales
- Participant personally signs the informed consent form and is willing to complete follow-up according to the study protocol
Who cannot join
- Current or past diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria, of bipolar disorder, schizophrenia spectrum and other psychotic disorders, neurocognitive disorders, neurodevelopmental disorders, or substance-related and addictive disorders
- Presence of significant psychotic symptoms, such as delusions or hallucinations
- Severe or unstable diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidneys, endocrine system, hematologic system, or other systems that, in the investigator's judgment, make the participant unsuitable for the study
- Evident suicide risk, defined as a score of 1 or higher on the suicide item of the 17-Item Hamilton Depression Rating Scale
- Active inflammatory disease
- Gastrointestinal infection, tumor, or other organic digestive disease, including but not limited to irritable bowel syndrome, Crohn disease, ulcerative colitis, or celiac disease
Show all 12Show fewer
- History of major gastrointestinal surgery
- Use of antibiotics, probiotics, prebiotics, or related functional products within 1 month before study entry
- Allergy to the study product or any of its components
- Pregnant or breastfeeding women
- Unable or unwilling to take the study product as required by the protocol
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Efficacy and Safety of Bifidobacterium PB-18 in Adults With Mild to Moderate Depressive Disorder and to Explore Its Gut-Brain Axis Mechanisms
The goal of this clinical trial is to learn if Bifidobacterium PB-18 can treat mild to moderate depressive disorder in adults aged 18 to 65 years who are not taking antidepressants or other psychotropic medications during the study. It will also learn about the safety of Bifidobacterium PB-18 and explore its potential effects on the gut-brain axis. The main questions it aims to answer are:
Does Bifidobacterium PB-18 increase the response rate at Week 8, defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17)?
Read more
What adverse events occur in participants receiving Bifidobacterium PB-18?
How do gut microbiota, metabolite profiles, and related biological markers change after treatment with Bifidobacterium PB-18?
Researchers will compare Bifidobacterium PB-18 with a placebo, a look-alike powder that does not contain PB-18, to see if Bifidobacterium PB-18 improves depressive symptoms.
Participants will:
Be randomly assigned to receive Bifidobacterium PB-18 or placebo in a 1:1 ratio Take the assigned study product once daily for 8 weeks Visit the study site at baseline, Week 4, and Week 8 for symptom and safety assessments Complete study questionnaires, including HAMD-17, HAMA, PSQI, and CBCT Provide blood and stool samples at baseline and Week 8 for exploratory biological analyses
Read the detailed description
This clinical trial is designed to evaluate whether Bifidobacterium PB-18 can improve symptoms in adults with mild to moderate depressive disorder who are not taking antidepressants or other psychotropic medications during the study. The study will also assess the safety of Bifidobacterium PB-18 and explore whether treatment-related changes in gut microbiota, metabolites, and other biological markers may help explain its potential effects through the gut-brain axis.
Depressive disorder is associated with a substantial disease burden, and many people with mild to moderate symptoms are reluctant to start antidepressant treatment because of concerns about adverse effects, delayed onset of action, or long-term medication use. Increasing evidence suggests that the gut-brain axis may play an important role in mood regulation. Bifidobacteria are probiotics that may influence emotional symptoms through effects on neurotransmitter-related pathways, inflammation, and stress responses. Based on preclinical findings and the study rationale described in the protocol, this trial will evaluate PB-18 as a potential non-drug intervention for this patient population.
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group exploratory study. A total of 88 eligible participants will be enrolled and randomly assigned in a 1:1 ratio to receive either Bifidobacterium PB-18 or placebo for 8 weeks. Participants in the active treatment group will take a daily powder containing 1 × 10^10 colony-forming units of PB-18. Participants in the placebo group will take a matching maltodextrin powder with the same appearance, color, smell, and taste but without PB-18. Study product allocation and coding will be managed independently, and participants, investigators, and outcome assessors will remain blinded during the study.
Eligible participants are adults 18 to 65 years of age who meet DSM-5 diagnostic criteria for depressive disorder and have a baseline HAMD-17 score from 7 to 24. Participants must be willing to complete study visits and must not use antidepressants or other psychotropic medications during the trial. The study includes three visits: baseline, Week 4, and Week 8. At these visits, participants will undergo clinical efficacy and safety assessments, and information on concomitant medications, prohibited medications, and adverse events will be recorded throughout the study.
The main efficacy endpoint is the difference between groups in response rate at Week 8, defined as the proportion of participants with at least a 50% reduction from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17). Secondary outcomes include remission rate at Week 8, response and remission at Week 4, and changes from baseline in HAMD-17, HAMA, PSQI, and CBCT scores across follow-up visits. Safety will be evaluated by monitoring adverse events and serious adverse events during the study.
To explore potential gut-brain axis mechanisms, blood and stool samples will be collected at baseline and Week 8. These samples will be used for exploratory analyses of gut microbiota, metabolite profiles, and related biological markers, and their relationships with changes in depressive symptoms may also be examined.
- Conditions
- Depressive Disorder
- Being tested
- Bifidobacterium, Placebo
- Keywords
- Bifidobacterium PB-18, Probiotic, Depression, Gut-Brain Axis, Placebo-Controlled, Randomized, Double-Blind
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifidobacteriumDietary supplement
Also called Bifidobacterium PB-18, Bifidobacterium longum subsp. infantis
Participants receive Bifidobacterium PB-18 powder orally once daily for 8 weeks. Each daily dose contains 1 × 10^10 CFU of PB-18. The study product is administered from baseline through Week 8.
PlaceboOther
Also called Maltodextrin placebo, Matching placebo
Participants receive a matching placebo powder orally once daily for 8 weeks. The placebo is maltodextrin and matches the PB-18 product in dose schedule, appearance, color, smell, taste, packaging, and administration, but does not contain PB-18.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium PB-18 | Experimental | Participants receive Bifidobacterium PB-18 powder orally once daily for 8 weeks. Each daily dose contains 1 × 10^10 CFU of PB-18. Receives: Dietary Supplement: Bifidobacterium |
| Placebo | Placebo comparator | Participants receive a matching placebo powder orally once daily for 8 weeks. The placebo is maltodextrin and matches the active product in appearance, color, smell, taste, packaging, and administration schedule, but does not contain PB-18. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate at Week 8 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in response rate at Week 8. Response is defined as a reduction of at least 50 percent from baseline in the total score on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Week 8
Secondary outcomes (7)
Remission Rate at Week 8 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in remission rate at Week 8. Remission is defined as a total score of 7 or less on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Week 8
Response Rate at Week 4 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in response rate at Week 4. Response is defined as a reduction of at least 50 percent from baseline in the total score on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Week 4
Remission Rate at Week 4 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in remission rate at Week 4. Remission is defined as a total score of 7 or less on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Week 4
Change From Baseline in Total Score on the 17-Item Hamilton Depression Rating Scale
Change from baseline in the total score on the 17-Item Hamilton Depression Rating Scale at follow-up visits. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline, Week 4, and Week 8
Change From Baseline in Total Score on the Hamilton Anxiety Rating Scale
Change from baseline in the total score on the Hamilton Anxiety Rating Scale at follow-up visits. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.
Measured: Baseline, Week 4, and Week 8
Change From Baseline in Total Score on the Pittsburgh Sleep Quality Index
Change from baseline in the total score on the Pittsburgh Sleep Quality Index at follow-up visits. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline, Week 4, and Week 8
Change From Baseline in Subscale Scores on the CBCT
Change from baseline in CBCT subscale scores at follow-up visits. Scores are calculated according to the standardized scoring system, with higher scores indicating changes in cognitive function as defined by the scale.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start5 May 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Model description
- Participants are randomly assigned in a 1:1 ratio to 1 of 2 parallel groups to receive either Bifidobacterium PB-18 or matching placebo for 8 weeks. The placebo matches the active product in appearance, color, smell, taste, and administration schedule. Participants, investigators, and outcome assessors remain blinded throughout the study unless emergency unblinding is required.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Lu, PhD, First Affiliated Hospital of Zhejiang University
- Investigators
- Jing Lu, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562516
- Sponsor's protocol ID
- IIT20260039C-R1
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Efficacy and Safety of Bifidobacterium PB-18 in Adults With Mild to Moderate Depressive Disorder and to Explore Its Gut-Brain Axis Mechanisms
- ClinicalTrials.gov ID
- NCT07562516
- Acronym / sponsor ID
- IIT20260039C-R1
- Conditions
- Depressive Disorder
- Keywords
- Bifidobacterium PB-18, Probiotic, Depression, Gut-Brain Axis, Placebo-Controlled, Randomized, Double-Blind
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 May 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.
The goal of this clinical trial is to learn if Bifidobacterium PB-18 can treat mild to moderate depressive disorder in adults aged 18 to 65 years who are not taking antidepressants or other psychotropic medications during the study. It will also learn about the safety of Bifidobacterium PB-18 and explore its potential effects on the gut-brain axis. The main questions it aims to answer are:
Does Bifidobacterium PB-18 increase the response rate at Week 8, defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17)?
What adverse events occur in participants receiving Bifidobacterium PB-18?
How do gut microbiota, metabolite profiles, and related biological markers change after treatment with Bifidobacterium PB-18?
Researchers will compare Bifidobacterium PB-18 with a placebo, a look-alike powder that does not contain PB-18, to see if Bifidobacterium PB-18 improves depressive symptoms.
Participants will:
Be randomly assigned to receive Bifidobacterium PB-18 or placebo in a 1:1 ratio Take the assigned study product once daily for 8 weeks Visit the study site at baseline, Week 4, and Week 8 for symptom and safety assessments Complete study questionnaires, including HAMD-17, HAMA, PSQI, and CBCT Provide blood and stool samples at baseline and Week 8 for exploratory biological analyses
Detailed description
This clinical trial is designed to evaluate whether Bifidobacterium PB-18 can improve symptoms in adults with mild to moderate depressive disorder who are not taking antidepressants or other psychotropic medications during the study. The study will also assess the safety of Bifidobacterium PB-18 and explore whether treatment-related changes in gut microbiota, metabolites, and other biological markers may help explain its potential effects through the gut-brain axis.
Depressive disorder is associated with a substantial disease burden, and many people with mild to moderate symptoms are reluctant to start antidepressant treatment because of concerns about adverse effects, delayed onset of action, or long-term medication use. Increasing evidence suggests that the gut-brain axis may play an important role in mood regulation. Bifidobacteria are probiotics that may influence emotional symptoms through effects on neurotransmitter-related pathways, inflammation, and stress responses. Based on preclinical findings and the study rationale described in the protocol, this trial will evaluate PB-18 as a potential non-drug intervention for this patient population.
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group exploratory study. A total of 88 eligible participants will be enrolled and randomly assigned in a 1:1 ratio to receive either Bifidobacterium PB-18 or placebo for 8 weeks. Participants in the active treatment group will take a daily powder containing 1 × 10^10 colony-forming units of PB-18. Participants in the placebo group will take a matching maltodextrin powder with the same appearance, color, smell, and taste but without PB-18. Study product allocation and coding will be managed independently, and participants, investigators, and outcome assessors will remain blinded during the study.
Eligible participants are adults 18 to 65 years of age who meet DSM-5 diagnostic criteria for depressive disorder and have a baseline HAMD-17 score from 7 to 24. Participants must be willing to complete study visits and must not use antidepressants or other psychotropic medications during the trial. The study includes three visits: baseline, Week 4, and Week 8. At these visits, participants will undergo clinical efficacy and safety assessments, and information on concomitant medications, prohibited medications, and adverse events will be recorded throughout the study.
The main efficacy endpoint is the difference between groups in response rate at Week 8, defined as the proportion of participants with at least a 50% reduction from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17). Secondary outcomes include remission rate at Week 8, response and remission at Week 4, and changes from baseline in HAMD-17, HAMA, PSQI, and CBCT scores across follow-up visits. Safety will be evaluated by monitoring adverse events and serious adverse events during the study.
To explore potential gut-brain axis mechanisms, blood and stool samples will be collected at baseline and Week 8. These samples will be used for exploratory analyses of gut microbiota, metabolite profiles, and related biological markers, and their relationships with changes in depressive symptoms may also be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to 1 of 2 parallel groups to receive either Bifidobacterium PB-18 or matching placebo for 8 weeks. The placebo matches the active product in appearance, color, smell, taste, and administration schedule. Participants, investigators, and outcome assessors remain blinded throughout the study unless emergency unblinding is required.
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium PB-18 | Experimental | Dietary Supplement: BifidobacteriumParticipants receive Bifidobacterium PB-18 powder orally once daily for 8 weeks. Each daily dose contains 1 × 10^10 CFU of PB-18. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive a matching placebo powder orally once daily for 8 weeks. The placebo is maltodextrin and matches the active product in appearance, color, smell, taste, packaging, and administration schedule, but does not contain PB-18. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatient or inpatient participants, aged 18 to 65 years (inclusive), of any sex
- Current episode meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for depressive disorder
- Baseline score on the 17-Item Hamilton Depression Rating Scale is 7 to 24, inclusive
- No concomitant use of antidepressants or other psychotropic medications during the study
- Elementary school education or above, able to understand the study requirements and complete the rating scales
Key exclusion criteria (12 listed)
- Current or past diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria, of bipolar disorder, schizophrenia spectrum and other psychotic disorders, neurocognitive disorders, neurodevelopmental disorders, or substance-related and addictive disorders
- Presence of significant psychotic symptoms, such as delusions or hallucinations
- Severe or unstable diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidneys, endocrine system, hematologic system, or other systems that, in the investigator's judgment, make the participant unsuitable for the study
- Evident suicide risk, defined as a score of 1 or higher on the suicide item of the 17-Item Hamilton Depression Rating Scale
- Active inflammatory disease
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 |
|---|---|---|
| BifidobacteriumAlso: Bifidobacterium PB-18, Bifidobacterium longum subsp. infantisParticipants receive Bifidobacterium PB-18 powder orally once daily for 8 weeks. Each daily dose contains 1 × 10^10 CFU of PB-18. The study product is administered from baseline through Week 8. | Dietary supplement | Bifidobacterium PB-18 |
| PlaceboAlso: Maltodextrin placebo, Matching placeboParticipants receive a matching placebo powder orally once daily for 8 weeks. The placebo is maltodextrin and matches the PB-18 product in dose schedule, appearance, color, smell, taste, packaging, and administration, but does not contain PB-18. | Other | Placebo |
Primary outcome
Response Rate at Week 8 Based on the 17-Item Hamilton Depression Rating Scale
Time frame: Week 8
Between-group difference in response rate at Week 8. Response is defined as a reduction of at least 50 percent from baseline in the total score on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
7 secondary outcomes
Remission Rate at Week 8 Based on the 17-Item Hamilton Depression Rating Scale
Time frame: Week 8
Response Rate at Week 4 Based on the 17-Item Hamilton Depression Rating Scale
Time frame: Week 4
Remission Rate at Week 4 Based on the 17-Item Hamilton Depression Rating Scale
Time frame: Week 4
Change From Baseline in Total Score on the 17-Item Hamilton Depression Rating Scale
Time frame: Baseline, Week 4, and Week 8
Change From Baseline in Total Score on the Hamilton Anxiety Rating Scale
Time frame: Baseline, Week 4, and Week 8
Change From Baseline in Total Score on the Pittsburgh Sleep Quality Index
Time frame: Baseline, Week 4, and Week 8
Change From Baseline in Subscale Scores on the CBCT
Time frame: Baseline, Week 4, and Week 8
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 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Jing Lu, PhD principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University.
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 6 inclusion and 12 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jing Lu, PhD (15858200010, Lujing2016@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate at Week 8 Based on the 17-Item Hamilton Depression Rating Scale (time frame: Week 8). 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 7 May 2026.