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临床试验/NCT03404557
NCT03404557已完成不适用

Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to Adherent-Invasive Escherichia Coli

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state

研究概览

简要总结

The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of the response of CD macrophages at a basal state and after the AIEC infection. These results consolidate the hypothesis of a defect specific to CD macrophages.

That's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative Colitis (UC) patients and healthy volunteers.

详细描述

The macrophages characterization will be realized at a basal state and in response or not to AIEC.

Investigator aimed to 1) better understand the differences between macrophages of CD patients, UC patients and healthy volunteers but also the impact of AIEC infection on these macrophages to provide key informations to detect and characterize the defect of these macrophages; 2) highlight one or several protein in CD macrophages that could represent, in a long term, a potential therapeutic target of CD.

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

  • - Crohn's Disease or ulcerative colitis or healthy volunteers
  • Age > 18 years
  • Patients benefiting from the health insurance plan
  • Patients who can read and attest to understanding the information note and informed consent

排除标准

  • Pregnant or breastfeeding woman
  • Under guardianship or curatorship
  • Refusing the genetic part of the study

结局指标

主要结局

Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state

时间窗: at day 1

Compare concentrations of different protein types in the supernatant of macrophages from patients with CD through proteomic approaches, compared with patients with UC or controls.

次要结局

  • presence of subgroups of patients with CD based on the proteomic profile of their macrophages.(at day 1)
  • Comparison of concentrations of different protein types in the supernatant of macrophages(at day 1)
  • associations between the Proteomic profile (s) of tissue macrophages and their AIEC status(at day 1)
  • associations between the Proteomic profile (s) of the macrophages derived from monocytes and their AIEC status(at day 1)
  • association between these subgroups of patients with CD and biological parameters.(at day 1)
  • associations between the levels of entry, survival and multiplication of AIEC bacteria(at day 1)
  • impact of anti-TNF treatment on the proteomic profile (s) observed for macrophages of patients with CD(at day 1)
  • associations between the proteomic profiles of macrophages of patients with CD, UC or control subjects and fecal AIEC status(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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