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临床试验/NCT03967236
NCT03967236已完成不适用

Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Evaluation over time of change of the gut virome

研究概览

简要总结

Over the last few years, dysbiosis has emerged as a possible trigger of gut inflammation in inflammatory bowel disease (IBD) and a promising therapeutic target. The complex diversity of microbiota was initially highlighted by the powerful new tools in genetics, including next-generation sequencing (NGS). NGS permitted to decipher the composition of bacterial intestinal communities, but also that of the gut virome. Since then, the evidence of a dynamic instability of the enteric virome in IBD has grown considerably. IBD patients present an expansion of bacteriophages (Caudovirales) associated with decreased bacterial diversity. Moreover, gut virome richness seems to differ between Crohn's disease (CD) and ulcerative colitis (UC) patients. These insights open the gate of new diagnostic, predictive, and therapeutic approaches. However, little is known about pediatric IBD gut virome in terms of variability and evolution under the influence of different treatments (exclusive enteral nutrition, immunosuppressive therapy and biologics). The aim of this study is to evaluate the gut family viral diversity and relative abundance of eukaryotes and prokaryotes in paediatric IBD patients

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 6-17 years
  • Follow-up in pediatric gastroenterology for inflammatory bowel disease :
  • Crohn's disease
  • Hemorrhagic rectocolitis
  • Introduction of anti-TNFa treatment in the Pediatric Gastroenterology Day Hospital of the "Hôpital Femme Mère Enfant" service in Lyon
  • Collection of the non-opposition of at least one of the holders of the parental authority present and the child in the medical file

排除标准

  • Refusal to participate in the study
  • Antibiotherapy in the 4 weeks preceding the sampling
  • Patient with ileostomy or colostomy.
  • Patient who has undergone extensive bowel resection.
  • History of intestinal surgery (except appendectomy)
  • Patient subject to a legal protection measure

结局指标

主要结局

Evaluation over time of change of the gut virome

时间窗: at the inclusion, 6 months and one year

Measure of alpha diversity by the Shannon index which takes into account the number of species present, but also the distribution of these species. Viral isolation, extraction, and amplification of viral nucleic acids from patient's stools. Next generation sequencing Statistical analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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