Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- PHQ-9 score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Patients who were participating in other clinical trials at the time of enrollment;
- •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.
研究组 & 干预措施
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.
干预措施: Intestinal flora capsule (Drug)
Placebo group
The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row.
干预措施: placebo capsule (Procedure)
结局指标
主要结局
PHQ-9 score
时间窗: 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.
次要结局
- 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.)
研究者
Yanling Wei
Deputy Chief Physician
Third Military Medical University