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

Ulcerative Colitis Clinical Trial

— ROMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404557
• Other study ID #: CHU-370
• Secondary ID: 2017-A00667-46
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Proteomic analysis
Proteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Laboratoire M2Ish

Country where clinical trial is conducted

France, 

Outcome

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