Fecal Microbiome Transplant in Pediatric C. Difficile
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of subjects with a recurrence of C. difficile (CDI)
研究概览
简要总结
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD)
The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
- •Age ≥ 3 years old.
- •Recurrent C. difficile or Moderate to Severe C. difficile.
- •Satisfactory completion of the medical interview and physical exam conducted by a study team member
- •Participants must be between 3 and 21 years of age (inclusive)
- •Signed informed consent form, and assent (if applicable)
排除标准
- •Patients <3 years old
- •Patients with other co-morbid intestinal infectious processes
- •Recipients with a history of severe (anaphylactic) food allergy
- •If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled.
- •Patients with severe IBD.
- •Ongoing/anticipated antibiotic use for non-CDI indication
- •Adverse event attributable to a previous FMT
- •Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
- •Any other condition for which the treating physician thinks the treatment may pose a health risk
- •Predicted death within time period of follow-up
- •Patients who are on supraphysiologic doses of corticosteroids
研究组 & 干预措施
C. Difficile without IBD
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
干预措施: Fecal Microbiota Transplant (Biological)
C. Difficile with IBD
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease
干预措施: Fecal Microbiota Transplant (Biological)
结局指标
主要结局
Number of subjects with a recurrence of C. difficile (CDI)
时间窗: 7 days
The hypothesis is that FMT will be an effective therapy for patients with IBD and CDI, resulting in resolution of symptoms as compared to historical controls on antibiotic therapy.
次要结局
未报告次要终点
研究者
Judith Kelsen
Attending Physician - CHCA
Children's Hospital of Philadelphia