CClinicalTrials.gg
CompletedNCT03404557ROMANUpdated Feb 4, 2019

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

An observational study in Crohn's Disease and Ulcerative Colitis, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
88
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Crohn's Disease
  • Ulcerative Colitis

Keywords

  • Crohn's Disease
  • Ulcerative colitis
  • Macrophages
  • Adherent-Invasive Escherichia coli
  • Proteomic analysis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with Crohn's disease

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

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Under guardianship or curatorship
  • Refusing the genetic part of the study
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and cohorts

  • Crohn's Disease patients group

    44 patients

    Other: Proteomic analysis

  • Ulcerative Colitis patients group

    22 patients

    Other: Proteomic analysis

  • Healthy volunteers group

    22 patients

    Other: Proteomic analysis

Interventions

  • OtherProteomic analysis

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at day 1

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

06

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
07

Registry details

Key details

Study ID
NCT03404557
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratoire M2Ish
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Jan 18, 2018
Primary completion
Jan 18, 2019
Completion
Jan 18, 2019
Last update
Feb 4, 2019

Study contacts

Anthony BUISSON
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion