Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC

Completed

• Conditions: Ulcerative Colitis; Crohn's Disease
• Interventions: Other: Proteomic analysis

• Registration Number: NCT03404557
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study Start: 2018-01-18
• Study First Posted: 2018-01-19
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• • 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers group	Proteomic analysis	22 patients
Ulcerative Colitis patients group	Proteomic analysis	22 patients
Crohn's Disease patients group	Proteomic analysis	44 patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France