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临床试验/NCT05321758
NCT05321758招募中不适用

Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年3月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Endoscopic remission

研究概览

简要总结

To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.

详细描述

Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

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
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of >10 and ≤40, and SES-CD of >3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy

排除标准

  • patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment

研究组 & 干预措施

FMT group

Active Comparator

Repeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.

干预措施: Fecal Microbiota Transplantation (Biological)

Immunosuppressive group

Sham Comparator

Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment.

干预措施: Immunosuppressive Agents (Drug)

结局指标

主要结局

Endoscopic remission

时间窗: 8-12 weeks after FMT

Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2

Clinical remission

时间窗: 8-12 weeks after FMT

Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10

Mucosal healing

时间窗: 8-12 weeks after FMT

Mucosal healing defined as SES-CD = 0

次要结局

  • Adverse events(2 and 10 weeks after FMT)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Biao Zou

attending physician

Tongji Hospital

研究点 (1)

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