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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis
• Intervention / Treatment: Other: Proteomic analysis

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 Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohn's Disease patients group; 44 patients	Other: Proteomic analysis; Proteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli
Ulcerative Colitis patients group; 22 patients	Other: Proteomic analysis; Proteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli
Healthy volunteers group; 22 patients	Other: Proteomic analysis; Proteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state	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.	at day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of concentrations of different protein types in the supernatant of macrophages	at day 1
presence of subgroups of patients with CD based on the proteomic profile of their macrophages.	at day 1
association between these subgroups of patients with CD and biological parameters.	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
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 profile (s) of the macrophages derived from monocytes and their AIEC status	at day 1
associations between the Proteomic profile (s) of tissue macrophages and their AIEC status	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Laboratoire M2Ish
• Investigators: Principal Investigator: Anthony Buisson, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): January 18, 2019

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Ulcerative colitis; Crohn's Disease; Macrophages; Proteomic analysis; Adherent-Invasive Escherichia coli
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CHU-370; 2017-A00667-46 (Other Identifier: 2017-A00667-46)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No