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PB-18 Probiotic for Mild to Moderate Depression

NCT07562516 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jing Lu, PhD · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2027-01-31
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562516 on ClinicalTrials.gov