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NOT YET RECRUITING

NCT07562516

PB-18 Probiotic for Mild to Moderate Depression

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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. 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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-05

Completion Date

2027-04-30

Last Updated

2026-05-07

Healthy Volunteers

Conditions

Depressive Disorder

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium

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.

OTHER

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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