NCT03267238已完成早期 1 期
Fecal Microbial Transplantation in Patients With Crohn's Disease
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
研究概览
简要总结
Fecal Microbiota Transplantation will be offered to eligible Crohn's disease patient as Investigational New Drug treatment
详细描述
The following hypothesis will be tested in this study:
- Fecal microbiota transplantation is a safe, tolerable procedure.
- The fecal microbial diversity, composition and function in stool recipients after fecal transplantation will change to a similar microbial diversity, composition and functionality as found in donor stool.
Primary objectives:
- To determine the short term safety and tolerability of fecal microbiota transplantation up to 12 weeks post-transplant in patients with Crohn's disease.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients less than 7 years of age
- •Scheduled for abdominal surgery within the next 12 weeks
- •Major abdominal surgery within the past 3 months
- •Pregnancy (This will be checked through a urine test on the day of procedure)
- •Anemia: Hemoglobin < 6 g/dL,
- •Neutropenia: Absolute Neutrophil Count <1500 Both of the above criteria will be checked via screening test or blood test reports within one month prior to the procedure
- •A known diagnosis of graft vs. host disease
- •Presence of an intra-abdominal or perianal abscess.
- •Presence of intestinal cutaneous fistula
- •Presence of severe intestinal stricture and/or intestinal obstruction
- •Administration of any investigational drug within the past 2 months
- •Use of a TNF-α antagonist within 2 weeks of the proposed date of transplantation
- •Bacteremia within past 4 weeks (28 days)
- •Severe Crohn's Disease, determined by Pediatric Crohns Disease Activity Index (PCDAI) value of more than
- •Individuals with severe prior allergic reaction to food;
- •Individuals with intercurrent illness including but not necessarily limited to: febrile illness, decompensated liver cirrhosis, HIV/AIDS BMT within past 150 days, malignancy, or other severe immunodeficiency.
- •Individuals at increased risk for complications of endoscopy or procedural sedation (e.g., ASA classification IV and above).
- •Previous FMT
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
时间窗: 5 years
Number of participants with treatment-related adverse events with grade greater than 2 within one year after FMT will be reported.
次要结局
- To measure the effect of fecal microbial transplantation on microbial function using targeted metabolomic assays.(6 years)
- To measure the effect of fecal microbial transplantation on microbial function using shotgun DNA metagenomic in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.(6 years)
- Determine if FMT causes a statistically significant change in recipient fecal calprotectin levels(6 years)
- To measure the effect of fecal microbial transplantation on microbial function using bacterial metatranscriptomic sequencing(6 years)
- To measure the effect of fecal microbial transplantation on microbial diversity in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.(6 years)
- To measure the effect of fecal microbial transplantation on microbial composition in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.(6 years)
研究者
Ellen Li
Professor
Stony Brook University
研究点 (2)
Loading locations...
相似试验
招募中
4 期
Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal (MIRACLE)2024-511822-30-00Assistance Publique Hopitaux De Paris350
已完成
1 期
FMT for Postop Crohn's DiseaseCrohn DiseaseNCT05248191University of Minnesota23
招募中
3 期
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF WithdrawalCrohn DiseaseNCT04997733Assistance Publique - Hôpitaux de Paris150
已完成
早期 1 期
Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate ColitisClostridium Difficile InfectionIndeterminate ColitisUlcerative ColitisNCT03268213Stony Brook University12
已完成
4 期
Fecal Microbiota TransplantClostridium Difficile InfectionNCT04090346Methodist Health System24