A Study of the Efficacy of Fecal Microbiota Transplantation(FMT) in the Treatment of Depression

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with depression were enrolled and randomly divided into two groups, namely FMT combined with antidepressant group and Antidepressant alone group.The former received FMT capsules and antidepressants, and the latter received oral placebo and antidepressants for an 8-week intervention.Before and after intervention, venous blood samples were collected from patients for routine tests such as liver and kidney function to judge the safety of treatment. At the same time, psychological scales were used to evaluate the improvement of patients' depressive symptoms, so as to judge the efficacy and safety of FMT combined with antidepressants.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Criteria

Inclusion Criteria:

• Aged from 18 to 65 years

• Patients with first-episode depression who met the International Classification of Diseases(ICD)-10 diagnosis of depression

• Hamilton Depression Scale (HAMD) score ≥17

• Informed consent was obtained.

Exclusion Criteria:

• Use of antibiotics within 1 month

• Women are pregnant and lactating

• Patients with severe unstable cardiovascular disease, liver disease, kidney disease, etc

• Patients with malignant tumor or serious systemic disease

• Suffering from other mental disorders such as bipolar disorder, obsessive-compulsive disorder

• It is accompanied by intestinal diseases that seriously damage the intestinal barrier, such as inflammatory bowel disease, Crohn's disease, intestinal tuberculosis, ischemic bowel disease, and radiation enteritis