Clinical trial NCT03404557: Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC
Official title: Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to Adherent-Invasive Escherichia Coli
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's Disease
Ulcerative colitis
Macrophages
Adherent-Invasive Escherichia coli
Proteomic analysis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Laboratoire M2Ish
First posted: 2018-01-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn's disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state
timeFrame: at day 1
Secondary outcomes:
measure: Comparison of concentrations of different protein types in the supernatant of macrophages
timeFrame: at day 1
measure: presence of subgroups of patients with CD based on the proteomic profile of their macrophages.
timeFrame: at day 1
measure: association between these subgroups of patients with CD and biological parameters.
timeFrame: at day 1
measure: associations between the proteomic profiles of macrophages of patients with CD, UC or control subjects and fecal AIEC status
timeFrame: at day 1
measure: associations between the levels of entry, survival and multiplication of AIEC bacteria
timeFrame: at day 1
measure: impact of anti-TNF treatment on the proteomic profile (s) observed for macrophages of patients with CD
timeFrame: at day 1
measure: associations between the Proteomic profile (s) of the macrophages derived from monocytes and their AIEC status
timeFrame: at day 1
measure: associations between the Proteomic profile (s) of tissue macrophages and their AIEC status
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Anthony BUISSON
role: PRINCIPAL_INVESTIGATOR
References: