NCT03115749

Brief Summary

The exact origin of inflammatory bowel disease (IBD) is still unknown. The current hypothesis is that IBD is secondary to an abnormal intestinal immun response directed to all or part of the intestinal flora in genetically predisposed individuals. Several experimental studies have demonstrated the ability of mesenchymal stem cells (MSCs) from bone marrow or adipose tissue origin to control intestinal inflammation in animal models. However, to date, there are no data regarding the functions of resident MSCs in the colon and small intestine of IBD patients. We hypothesize that dysfunction of resident intestinal MSCs contributes to the disruption of intestinal homeostasis in patients with IBD causing the development of intestinal inflammation. The aim of this research project is to identify, describe and characterize at the molecular and functional level MSCs of the colon and small intestine of patients with Crohn's disease and ulcerative colitis and to compare them with a control population.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

April 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

April 10, 2017

Last Update Submit

December 27, 2021

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn's diseaseulcerative colitismesenchymal stem cellsintestinal inflammation

Outcome Measures

Primary Outcomes (1)

  • Proliferation and differentiation of intestinal MSCs in IBD patients.

    Proliferation and differentiation of intestinal MSCs in IBD patients.

    1 month

Secondary Outcomes (1)

  • Comparison of MSCs between IBD patients and control patients

    1 month

Study Arms (3)

Crohn's disease patient group

OTHER

Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection

Other: Intestinal biopsies during colonoscopyOther: Biopsies taken on surgical specimen

Ulcerative colitis patient group

OTHER

Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection

Other: Intestinal biopsies during colonoscopyOther: Biopsies taken on surgical specimen

Control group

OTHER

Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection

Other: Intestinal biopsies during colonoscopyOther: Biopsies taken on surgical specimen

Interventions

Intestinal biopsies during colonoscopyOTHER

Intestinal biopsies during colonoscopy

Control groupCrohn's disease patient groupUlcerative colitis patient group
Biopsies taken on surgical specimenOTHER

biopsies taken on surgical specimen after intestinal resection

Control groupCrohn's disease patient groupUlcerative colitis patient group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For IBD patients :
  • Age between 18 and 75 year old
  • Diagnosis of Crohn's disease or ulcertaive colitis according to internationla guidelines
  • Endoscopically active disease
  • Indication for colonoscopy or intestinal resection according to standard of care
  • Written inform consent
  • For control patients :
  • Age between 18 and 75 year old
  • Indication for screening colonoscopy for irritable bowel syndrome, diverticulum or colorectal cancer surveillance according to standard of care
  • Indication for intestinal resection for diverticulum or colorectal cancer according to standard of care
  • Written inform consent

You may not qualify if:

  • For IBD patients :
  • Active intestinal infection
  • Confirmed intestinal parasitosis
  • Intestinal stoma
  • For control patients :
  • Active intestinal infection
  • Confirmed intestinal parasitosis
  • Intestinal inflammation at colonoscopy
  • Chronic intestinal inflammation on biopsies
  • Absence of healthy tissue on surgical specimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital St Eloi

Montpellier, 34080, France

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Guillaume Pineton de Chambrun

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 14, 2017

Study Start

November 21, 2018

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)