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Clinical application of fecal bacteria transplantation in the treatment of adolescent depression

A positive drug-controlled trial of FMT to improve efficacy in adolescents with first-episode depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087124
Enrollment
Unknown
Registered
2024-07-19
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Experimental group:Take FMT capsules
Control group:Take Sertraline

Sponsors

The First Affiliated Hospital of Xi 'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: ?12 years old =18 years old; ? In line with the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-V) "major depressive disorder" diagnostic criteria; ? The first episode, 12 points = Montgomery Depression Scale (MADRS) score =30 points; ? This episode has not been treated with effective antidepressant therapy (antidepressant drugs have not reached the effective dose or reached the effective dose but the course of treatment is less than 2 weeks); ? Right-handed; ? Primary school education and above; ? I and my guardian know and agree to participate in this project.

Exclusion criteria

Exclusion criteria: ? Use antibiotics within 1 month or there is an active infection; ? The female is pregnant or lactating; ? Suffering from serious unstable cardiovascular disease, liver disease, kidney disease, etc.; ? Suffering from malignant tumor disease or serious systemic disease; ? Suffering from other mental disorders, such as bipolar disorder, compulsive disorder; ? Accompanied by intestinal diseases that severely damage the intestinal barrier, such as inflammatory bowel disease; Previous suicidal behavior or family history of suicide, or current MADRS 10 > 2 points; ? Poor treatment compliance; ? Any other conditions that the investigator deems unsuitable for inclusion

Design outcomes

Primary

MeasureTime frame
Montgomery depression scale;

Secondary

MeasureTime frame
Hamilton anxiety scale;9 items Patient health questionnaire;Clinical Global Impression;

Countries

China

Contacts

Public ContactMa Xiancang, Zhu Feng

The First Affiliated Hospital of Xi 'an Jiaotong University

maxiancang@163.com+86 130 0295 1782

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026