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

Third Military Medical University

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Procedure: placebo capsule; Drug: Intestinal flora capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05030064

TMMU-DP-GI-FMT-003

Details and patient eligibility

About

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.

Full description

A total of 54 patients with definite diagnosis of ulcerative colitis (light-to-moderate active period) with depressive state were included. According to the random table, patients were randomly divided into the FMT capsule group and the placebo group, and received the FMT capsule and placebo interventions once a week for 4 consecutive times, respectively. The patients were followed up at the 4th, 8th and 12th week of intervention, and a simple physical examination was performed to evaluate the patient's condition changes (abdominal pain degree score, diarrhea frequency, stool characteristics and extraintestinal manifestations such as skin and joints) and modified Mayo score , IBD-QOL scale, PHQ9, SDS, HADS, HAMA, HAMD scale, etc. The improvement and effective colonization of the intestinal flora in the FMT capsule group or the placebo group of patients with depression and IBD were observed by methods such as 16S rRNA analysis of the intestinal flora In the 12th weeks.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups, including a placebo group

Intestinal flora capsule(FMT)

Experimental group

Description:

The group includes 27patients.They will receive 16 capsules of intestinal bacteria each time, once a week, 4 times in a row.Each capsule contains 200mg of fecal bacteria.

Treatment:

Drug: Intestinal flora capsule

Placebo group

Placebo Comparator group

Description:

The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row.

Treatment:

Procedure: placebo capsule