The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.
详细描述
The study will be conducted in two parts. The first part will involve all patients undergoing an optimisation phase, followed by randomisation into either intervention or placebo arms of the induction phase of the study. For patients achieving a pre-determined clinical response threshold at week 8 they will be re-randomised into the maintenance phase of the trial for a further 44 weeks.
FMT will be anaerobically prepared, freeze-thawed for administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomisation tables will be computer generated by an independent statistician. The indistinguishable aspect of the FMT syringes (colour, packaging) will ensure the blindness of both patients and physicians in charge.
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
- •Active Crohn's disease
- •Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND
- •CDAI score of 220-450 AND
- •One of the following:
- •CRP ≥5mg/L
- •faecal calprotectin ≥100μg/g
- •inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)
- •Willing and able to attend the study sites for regular endoscopic procedures.
排除标准
- •Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose >20mg or budesonide dose >6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.
研究组 & 干预措施
FMT arm
Anaerobically prepared, freeze-thawed faecal microbiota transplantation
干预措施: Antibiotics (Drug)
FMT arm
Anaerobically prepared, freeze-thawed faecal microbiota transplantation
干预措施: Dietician designed diet (Dietary Supplement)
FMT arm
Anaerobically prepared, freeze-thawed faecal microbiota transplantation
干预措施: FMT (Drug)
Placebo arm
Placebo liquid formulation (normal saline, glycerol, food colorant)
干预措施: Antibiotics (Drug)
Placebo arm
Placebo liquid formulation (normal saline, glycerol, food colorant)
干预措施: Dietician designed diet (Dietary Supplement)
Placebo arm
Placebo liquid formulation (normal saline, glycerol, food colorant)
干预措施: Placebo (Other)
结局指标
主要结局
Clinical response
时间窗: Week 8
CDAI decrease of ≥100 or CDAI\<150
次要结局
- Clinical remission(Week 8 and week 52 or Week 16 and week 60 (for open FMT group))
- Endoscopic response(Week 8 and 52 or Week 16 and 60)
- Endoscopic remission(Week 8 and week 52 Week 16 and 60)
- Histological Remission(Week 8 and 52 or Week 16 and 60)
- Radiological remission(Week 8 and 52 or Week 16 and 60)
- Biochemical response(Week 8 and 52 or Week 16 and 60)
- Time to outcomes(Duration of trial)
- Maintenance of clinical remission(Weeks 52 or 60)
- Sustained clinical remission(Weeks 52 or 60)
- Steroid-free clinical remission(Weeks 52 or 60)
- Safety outcomes(Duration of trial)
- Scientific outcomes(Week 8 and 52 or Week 16 and 60)
研究者
Michael Kamm
The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
St Vincent's Hospital Melbourne