Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center trial, randomized, single-blind, placebo-controlled clinical intervention study which intends to explore the safety and effectiveness of FMT capsule for the treatment of ulcerative colitis with depression.

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

Details

• Lead Sponsor: Third Military Medical University

Criteria

Inclusion Criteria:

1. The course of the disease is more than 6 months, and it is clearly diagnosed as ulcerative colitis with depression.【Diagnostic criteria: (2020) "JSGE Evidence-based Clinical Practice Guidelines: Inflammatory Bowel Disease" and "Chinese Mental Disorders Classification and Diagnostic Standards" (CCMD) -3) The relevant standards in the above, and also meet the improved Mayo score ≤ 10 points, PHQ9 score ≥ 5 points】;

2. There is no restriction on men and women, aged between 18-65 years old;

3. BMI is between 18-30kg/m2;

4. Have basic reading comprehension skills;

5. No other serious diseases such as heart, brain, lung, liver, and kidney are complicated;

6. Have not traveled abroad in the past month, and have no history of alcoholism, drug abuse, or smelting;

7. No antibiotics and probiotic preparations have been used within one month;

8. Agree to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Age <18 years old or >65 years old;

2. Patients with unspecified ulcerative colitis;

3. Authors with bipolar disorder, persistent mood disorder, and mania;

4. Malignant tumors such as gastrointestinal infection, irritable bowel syndrome, bowel cancer and other gastrointestinal diseases;

5. A history of gastrointestinal surgery;

6. Patients during pregnancy and lactation;

7. Complicated with obesity, hypertension, diabetes, heart disease, stroke and other serious chronic diseases (hereditary, metabolic, endocrine diseases);

8. Infectious diseases: hepatitis B or C, HIV, syphilis (rapid recovery of positive plasma), Epstein-Barr virus and cytomegalovirus infection (IgM positive);

9. Abnormal liver function: AST or ALT higher than 2 times the upper limit of normal; renal insufficiency: serum Cr higher than 1.5 times the upper limit of normal or eGFR<60ml/min; dyslipidemia (TC> 4.0 mmol/L, TG >2.0 mmol/L, LDL-c>2.5 mmol/L, HDL-c<1.0 mmol/L), CRP>8mg/L;

10. Anticoagulation therapy;

11. Patients who were participating in other clinical trials at the time of enrollment;

12. Those who do not agree to join the group or have various factors affecting compliance and other people who are not suitable for participating in clinical trials.