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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03404557
Acronym
ROMAN
Enrollment
88
Registered
2018-01-19
Start date
2018-01-18
Completion date
2019-01-18
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Crohn's Disease, Ulcerative colitis, Macrophages, Adherent-Invasive Escherichia coli, Proteomic analysis

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.

Interventions

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

Sponsors

Laboratoire M2Ish
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal stateat day 1Compare 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

MeasureTime frame
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 statusat day 1
Comparison of concentrations of different protein types in the supernatant of macrophagesat day 1
impact of anti-TNF treatment on the proteomic profile (s) observed for macrophages of patients with CDat day 1
associations between the Proteomic profile (s) of the macrophages derived from monocytes and their AIEC statusat day 1
associations between the Proteomic profile (s) of tissue macrophages and their AIEC statusat day 1
associations between the levels of entry, survival and multiplication of AIEC bacteriaat day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026