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

NCT05850572 | Not Yet Recruiting

• 2 other identifiers: 82022023-12021GXLH-Z-083-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Hamilton Depression Scale

  Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.

  At the beginning of treatment

• Hamilton Depression Scale

  Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.

  At the end of 4 weeks

• Hamilton Depression Scale

  Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.

  At the end of 8 weeks

Study Arms (2)

Fecal microbiota transplantation(FMT)

EXPERIMENTAL

Subjects will receive FMT capsules (10\^12 CFU/capsule) in addition to their usual antidepressant treatment. Subjects will continue to receive FMT capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.

Drug: Fecal microbiota transplantation(FMT)

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antidepressant treatment. Placebo capsules contained the food probiotic Lactobacillus (10\^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.

Other: Placebo

Interventions

Fecal microbiota transplantation(FMT) DRUG

Subjects will receive FMT capsules (10\^12 CFU/capsule) in addition to their usual antidepressant treatment. Subjects will continue to receive FMT capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.

Fecal microbiota transplantation(FMT)

Placebo OTHER

Participants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antidepressant treatment. Placebo capsules contained the food probiotic Lactobacillus (10\^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Depression

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Feng Zhu, professor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Feng Zhu, professor

CONTACT

0086-13571827380; zhufeng0714@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 9, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2023

Record last verified: 2023-04