Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Overview
- Phase
- Not Applicable
- Intervention
- Intestinal flora capsule
- Conditions
- Ulcerative Colitis
- Sponsor
- Third Military Medical University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- PHQ-9 score
- Last Updated
- 4 years ago
Overview
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.
Investigators
Yanling Wei
Deputy Chief Physician
Third Military Medical University
Eligibility Criteria
Inclusion Criteria
- •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】;
- •There is no restriction on men and women, aged between 18-65 years old;
- •BMI is between 18-30kg/m2;
- •Have basic reading comprehension skills;
- •No other serious diseases such as heart, brain, lung, liver, and kidney are complicated;
- •Have not traveled abroad in the past month, and have no history of alcoholism, drug abuse, or smelting;
- •No antibiotics and probiotic preparations have been used within one month;
- •Agree to participate in this study and sign an informed consent form.
Exclusion Criteria
- •Age \<18 years old or \>65 years old;
- •Patients with unspecified ulcerative colitis;
- •Authors with bipolar disorder, persistent mood disorder, and mania;
- •Malignant tumors such as gastrointestinal infection, irritable bowel syndrome, bowel cancer and other gastrointestinal diseases;
- •A history of gastrointestinal surgery;
- •Patients during pregnancy and lactation;
- •Complicated with obesity, hypertension, diabetes, heart disease, stroke and other serious chronic diseases (hereditary, metabolic, endocrine diseases);
- •Infectious diseases: hepatitis B or C, HIV, syphilis (rapid recovery of positive plasma), Epstein-Barr virus and cytomegalovirus infection (IgM positive);
- •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;
- •Anticoagulation therapy;
Arms & Interventions
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.
Intervention: Intestinal flora capsule
Placebo group
The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row.
Intervention: placebo capsule
Outcomes
Primary Outcomes
PHQ-9 score
Time Frame: 12 Weeks after treatment.
Patien Health Questionnare.The total score is 0-27 points, 0-4 points: no depression; 5-9 points: mild depression; 10-14 points: moderate depression; 15-27 points: severe depression. The higher the score, the worse the depression.
Secondary Outcomes
- HAMA-score(12 Weeks after treatment.)
- HAMD-score(12 Weeks after treatment.)
- IBD-QoL(12 Weeks after treatment.)
- Modified Mayo score(12 Weeks after treatment.)
- SDS-score(12 Weeks after treatment.)
- HADS-score(12 Weeks after treatment.)
- GSRS-score(12 Weeks after treatment.)