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Clinical study of Fecal microbiota transplantation(FMT) in the treatment of major depressive disorder(MDD)

Clinical study of Fecal microbiota transplantation in the treatment of major depressive disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063653
Enrollment
Unknown
Registered
2022-09-14
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Major depressive disorder

Interventions

experimental group:FMT capsule

Sponsors

First Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) age: 18-65 years old, male or female; (2) meet the diagnostic criteria of MDD in DSM-5 and apply SCID-5-RV as standardized clinical diagnostic screening tool; (3) HAMD-17 score > 17; (4) first onset and no medication; (5) gastrointestinal symptoms in the last 2 weeks or more; (6) no obvious suicidal thoughts; (7) patients and their families fully understand the treatment process and mechanism of FMT, and sign informed consent; (8) can swallow capsules by oneself.

Exclusion criteria

Exclusion criteria: (1) patients with major physical diseases or a history of craniocerebral trauma; (2) currently have serious suicidal tendencies or serious impulsive tendencies; (3) suffering from other neuropsychiatric diseases; (4) intestinal organic lesions, such as hirschsprung's disease, intestinal obstruction, intussusception, etc; (5) pathological intestinal inflammatory changes, such as inflammatory bowel disease; (6) severe obesity or severe malnutrition; (7) planned use of probiotics, antibiotics and other drugs that clearly affect intestinal flora in the last 3 months or in the next 6 months; (8) have received FMT treatment within the last 12 months; (9) pregnant or breast-feeding women; (10) can not swallow capsules.

Design outcomes

Primary

MeasureTime frame
Gut microbiota;Serum metabolites;Electroencephalogram;Scale evaluation;

Countries

China

Contacts

Public ContactLiu Penghong
liupenghong6@163.com18834180209

Outcome results

None listed

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