Clinical trial NCT05030064: Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Official title: Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis，Depression，FMT
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is planned to recruit UC patients with depression and voluntarily receive standard enterobacteria capsule or placebo treatment. A total of 54 cases will be completely randomized according to the random number table and randomly divided into 2 groups for intervention.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PHQ-9 score
timeFrame: 12 Weeks after treatment.
Secondary outcomes:
measure: SDS-score
timeFrame: 12 Weeks after treatment.
measure: HAMA-score
timeFrame: 12 Weeks after treatment.
measure: HAMD-score
timeFrame: 12 Weeks after treatment.
measure: HADS-score
timeFrame: 12 Weeks after treatment.
measure: GSRS-score
timeFrame: 12 Weeks after treatment.
measure: Modified Mayo score
timeFrame: 12 Weeks after treatment.
measure: IBD-QoL
timeFrame: 12 Weeks after treatment.
Other outcomes:
measure: WBC
timeFrame: 12 Weeks after treatment.
measure: CRP
timeFrame: 12 Weeks after treatment.
measure: ESR
timeFrame: 12 Weeks after treatment.
measure: PCT
timeFrame: 12 Weeks after treatment.
measure: IL-6
timeFrame: 12 Weeks after treatment.
measure: Intestinal flora
timeFrame: 12 Weeks after treatment.
Locations:
city: Chongqing
country: China
facility: Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
affiliation: Army Medical Center
name: Wei Y Ling
role: PRINCIPAL_INVESTIGATOR
References: