NCT03404557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

January 12, 2018

Last Update Submit

February 1, 2019

Conditions

Crohn's DiseaseUlcerative Colitis

Keywords

Crohn's DiseaseUlcerative colitisMacrophagesAdherent-Invasive Escherichia coliProteomic analysis

Outcome Measures

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.

    at day 1

Secondary Outcomes (8)

  • Comparison of concentrations of different protein types in the supernatant of macrophages

    at day 1

  • 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 status

    at day 1

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

    at day 1

  • +3 more secondary outcomes

Study Arms (3)

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

Proteomic analysisOTHER

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

Crohn's Disease patients groupHealthy volunteers groupUlcerative Colitis patients group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Crohn's disease

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Anthony BUISSON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

January 18, 2018

Primary Completion

January 18, 2019

Study Completion

January 18, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)