Safety and Efficacy of Heterologous Fecal Microbiota Transplantation (FMT) by Standardized Quantitative Multi-donor Intestinal Microbiota Capsule (SQIMC-md) in Mild-moderate Ulcerative Colitis Patients-a Multi-center Double-blind RCT Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 99
- 主要终点
- Clinical response rate at week 8 after SQIMC-md treatment.
研究概览
简要总结
This study aims to assess the safety and efficacy of heterologous fecal microbiota transplantation (FMT) by Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md) in mild-moderate ulcerative colitis patients who fail to achieve clinical remission over 4 weeks after full dose 5-Aminosalicylic acid(5-ASA). Intestinal microbiota transplant for FMT will be prepared from multiple healthy donors and prepared by standardized procedure with fixed quantitative dosage. This strategy might offer a novel and safe therapeutic approach for these patients before step up to corticosteroid, immunosuppressant or biologics therapy.
详细描述
All candidates for mild-moderate ulcerative colitis treated in Dept. Gastroenterology, Tongji Hospital, Tongji Medical College of HUST, the second Xiangya Hospital of central south university and the first affiliated Hospital of Zhengzhou University will be screened for study inclusion and exclusion criteria. All consenting patients will 2:1 randomized into SQIMC-md treatment group or Placebo group. Three dose of SQIMC-md capsule will be orally administrated on day1, day2 and day3. Follow-up will be performed every 4 weeks and last for 12weeks. Full dose of 5-ASA is orally administrated simultaneously during the study. Clinical data and outcome will be collected and documented in electronic case reported form (eCRF).
FMT DONORS:
Potential healthy adult stool donors (between 18 and 28 years of age) will be recruited by the research staff. They will be asked to volunteer for the screening and regularly supply stool samples according to the study protocol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of ulcerative colitis based on clinical symptoms, as well as laboratory and colonoscopic findings, including histopathologic results of the intestinal mucosa.
- •Ulcerative Colitis complete Mayo score range from 4 to 10 [mild-moderate activity] and Mayo endoscopic score ≥2 as assessed within 4 weeks prior to enrollment and clinical symptoms that are at least stable.
- •Patients failed to acquire clinical remission after full dose and adequate course (4 weeks) of 5-ASA or precursors treatment.
- •Patients ≥ 18 and < 70 years of age are eligible for this trial.
- •All patients must sign a written informed consent document. Assent, when appropriate, will be obtained according to institutional guidelines.
排除标准
- •Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) or other severe immunodeficiency
- •Patients with severe prior allergic reaction to food or supplementary material of placebo will be excluded from the protocol.
- •Patients who are pregnant or lactating will be excluded from the protocol.
- •Suspected as CMV or EBV colitis by endoscopic findings and proved by immunohistochemistry and biopsy PCR.
- •Decompensated life-threatening disease including but not restricted to liver cirrhosis (bleeding varices, ascites, encephalopathy or icterus), heart attack, malignancy and so on.
研究组 & 干预措施
Placebo capsule arm
Oral administration of 30 placebo capsule containing edible pigmented starch together with full dose of oral 5-Aminosalicylic acid(5-ASA).
干预措施: placebo capsule (Procedure)
SQIMC-md FMT arm
Oral administration of 30 SQIMC-md capsules containing 2*10^13 copies of prepared fecal microbiota lyophilized powder from multiple healthy donors' fresh feces together with full dose of oral 5-Aminosalicylic acid(5-ASA).
干预措施: Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md) (Procedure)
结局指标
主要结局
Clinical response rate at week 8 after SQIMC-md treatment.
时间窗: 8 weeks
Assess efficacy of SQIMC-md FMT treatment with the aid of the Mayo score for Ulcerative Colitis clinical disease severity and response rate at week 8 after SQIMC-md treatment. Mayo score (Disease activity index) for Ulcerative Colitis. Total range for complete Mayo score 0-12 (sum from 4 subscales below) and partial Mayo score 0-9 (sum from 1,2 and 4 subscales below): Each subscale for mayo score: 1. Stool frequency: 0-3 2. Rectal bleeding: 0-3 3. Mayo endoscopic score: 0-3 4. Estimation from physician: 0-3 Clinical response rate is defined as a decrease of ≥ 3 points and at least 30% from baseline in the Mayo score, with an accompanying decrease of ≥ 1 point in the subscore for rectal bleeding or an absolute subscore ≤ 1 for rectal bleeding
次要结局
- Incidence of Treatment-Emergent Adverse Events(12 weeks)
- the remission rate at week12(12 weeks)
- Mean (or median) decrease of fecal calprotectin(12 weeks)
- clinical response rate at week4 and week12(week4 and week12)
- Mean (or median) change from baseline in Inflammatory Bowel Disease Questionnaire （IBDQ） total score and subscore at week 12(12 weeks)