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临床试验/NCT03194529
NCT03194529已完成1 期

Safety of FMT in Maintenance of Pediatric Crohn's Disease

Children's Hospital Los Angeles2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年10月9日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
9
试验地点
2
主要终点
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

研究概览

简要总结

The goal of this study is to evaluate the safety of Fecal Microbiota Transplantation (FMT) in children with Crohn's disease who are in remission. Safety will be the primary endpoint and Pediatric Crohn's Disease. Pediatric Crohn's Disease Activity Index (PCDAI) with other secondary endpoints including changes in gut microbial diversity will also be studied. All children will receive the equivalent of 50g of stools from a healthy donor into the jejunum through upper endoscopy. Also, 1-2 additional mucosal biopsies will be collected during patient's routine (standard of care) endoscopy. Subjects will have a total of 5 study visits within 24 weeks including phone call follow up on Day 7 after FMT.

详细描述

The Investigators hypothesize that children with Crohn's disease who are in remission can receive a single endoscopic dose of FMT with no significant safety concerns.

All children will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy. Children will be seen at baseline, then 4 and 24 weeks after study drug administration begins. Stools will be collected and stored for gut microbial profiles during the study visit windows. In addition, a follow up telephone call will be performed 7 days after study drug is administered. If children undergo endoscopy as part of the standard of care, study staff will obtain 1-2 additional biopsies for evaluation of mucosal inflammation. This study will also capture any laboratory results if any of the subjects undergo laboratory testing as part of the standard of care. This study will define the effects of transplant on gut microbial profile using advanced molecular taxonomic approaches. Safety will be closely monitored by solicited (during defined telephone calls and study visits) and unsolicited adverse events (at all times). Safety will be the primary endpoint of this study. Secondary endpoints include Pediatric Crohn's Disease Activity Index (PCDAI), changes in gut microbial diversity - determined by gut microbial genomics and proteomics (16S ribosomal RNA, 16s rRNA), and outcome measures for mucosal inflammation and repair as reflected through laboratory testing such as the level for C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), inflammatory cytokines of the colonic mucosa as well as the stool calprotectin level.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 7-21 who have been diagnosed with Crohn's disease
  • Remission of disease defined as PCDAI <10
  • Needs upper GI endoscopy

排除标准

  • Unwilling to give informed consent/assent
  • Pregnancy and breast feeding in patient subjects of childbearing potential
  • Subjects with significant renal and liver dysfunction (creatinine > 2 mg/dl and direct bilirubin > 2 mg/dl)
  • Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed due to conditions other than Crohn's disease (such as neoplastic disease or organ transplantation), have received or are receiving chemotherapy, or have been diagnosed with HIV.
  • Subjects with severe food allergies

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

时间窗: 24 weeks

Safety will be closely monitored (during defined telephone calls and study visits) and adverse events will be documented, including mucosal inflammation episodes and standard of care laboratory test abnormalities.

次要结局

  • Crohn's disease activity(24 weeks)
  • Changes in gut microbiome(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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