跳至主要内容
临床试验/NCT06614738
NCT06614738招募中不适用

Microbial and Environmental Factors Associated With Polyps Development in Familial Adenomatous Polyposis

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
4
主要终点
Fecal microbiota composition

研究概览

简要总结

Familial adenomatous polyposis (FAP) is an autosomal dominant inherited disorder linked to a mutation in the APC gene, associated with the development of multiple colonic and duodenal adenomas, which in 100% of cases progress to colorectal cancer (CRC) if left untreated. Management of affected patients is usually based on prophylactic total colectomy with or without rectal preservation, followed by regular endoscopic surveillance of the duodenum and rectum or ileal reservoir. However, there is considerable inter- and intra-familial variability in the rate of adenoma appearance and development for identical mutations. This strongly suggests the additional role of environmental factors. Recently, the gut microbiota has been identified as a co-factor of carcinogenesis in patients with FAP, but no prospective evaluation of the association between the incidence and severity of adenomatous proliferations and a microbiological signature has been studied, particularly at duodenal level in operated patient.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 years
  • Non-opposition obtained
  • Prophylactic colectomy for at least 2 years in the context of APC-related familial adenomatous polyposis with ileorectal or ileoanal anastomosis
  • Included in the national POLYPOSE database
  • Regular endoscopic follow-up with upper and lower GI endoscopy at Hôpital Edouard Herriot or Hôpital de la Croix-Rousse
  • Having performed at least 2 endoscopies as part of follow-up

排除标准

  • Antibiotic therapy within 2 months prior to stool sampling
  • Taking probiotics for less than 1 month
  • Person deprived of liberty by judicial or administrative decision

结局指标

主要结局

Fecal microbiota composition

时间窗: Within 48 hours of endoscopy

Analysis of fecal microbiota composition as a function of the cumulative number of reservoir (rectum or ileal) adenomas treated over 3 consecutive endoscopies

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 (4)

Loading locations...

相似试验