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

NCT ID: NCT05030064

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-08-31

Brief 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.

Detailed 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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intestinal flora capsule(FMT)

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.

Group Type: EXPERIMENTAL

Intestinal flora capsule

Intervention Type: DRUG

This research group has independently researched and created a human intestinal flora capsule based on "intestinal bacteria transplantation": Intestinal flora capsule, which has been declared a national invention patent (patent number: 2015103040414).

Placebo group

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

Group Type: PLACEBO_COMPARATOR

placebo capsule

Intervention Type: PROCEDURE

Each placebo capsule is the two-layer empty capsule shell of the Intestinal flora capsule, which is made of titanium dioxide and iron oxide yellow. It is non-toxic and has the same appearance as the authentic Intestinal flora capsule.

Interventions

Intestinal flora capsule

This research group has independently researched and created a human intestinal flora capsule based on "intestinal bacteria transplantation": Intestinal flora capsule, which has been declared a national invention patent (patent number: 2015103040414).

Intervention Type: DRUG

placebo capsule

Each placebo capsule is the two-layer empty capsule shell of the Intestinal flora capsule, which is made of titanium dioxide and iron oxide yellow. It is non-toxic and has the same appearance as the authentic Intestinal flora capsule.

Intervention Type: PROCEDURE

Other Intervention Names

Fecal Bacteria Transplant; Placebo control

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yanling Wei

Deputy Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Y Ling

Role: PRINCIPAL_INVESTIGATOR

Army Medical Center

Locations

Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanling Wei, doctorate

Role: CONTACT

lingzi016@126.com

15310354666

Dongfeng Chen, doctorate

Role: CONTACT

chendf1981@126.com

13883032812

Facility Contacts

Dongfeng Chen, doctor

Role: primary

chendf1981@126.com

86-13883032812

Yanling Wei, doctor

Role: backup

lingzi016@126.com

86-15310354666

Other Identifiers

TMMU-DP-GI-FMT-003

Identifier Type: -

Identifier Source: org_study_id