Skip to main content
OpenTrials
Completed

NCT Number: NCT03404557

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proteomic analysis

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Comparison of concentrations of different protein types in the supernatant of macrophages

    Time frame: at day 1

  2. presence of subgroups of patients with CD based on the proteomic profile of their macrophages.

    Time frame: at day 1

  3. association between these subgroups of patients with CD and biological parameters.

    Time frame: at day 1

  4. associations between the proteomic profiles of macrophages of patients with CD, UC or control subjects and fecal AIEC status

    Time frame: at day 1

  5. associations between the levels of entry, survival and multiplication of AIEC bacteria

    Time frame: at day 1

  6. impact of anti-TNF treatment on the proteomic profile (s) observed for macrophages of patients with CD

    Time frame: at day 1

  7. associations between the Proteomic profile (s) of the macrophages derived from monocytes and their AIEC status

    Time frame: at day 1

  8. associations between the Proteomic profile (s) of tissue macrophages and their AIEC status

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Laboratoire M2Ish

Registry information

Official study title

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

Acronym: ROMAN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2018
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.