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Intestinal Stem Cells Characterization (BIODIGE)

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ClinicalTrials.gov Identifier: NCT02874365
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Procedure: Endoscopic biopsies Not Applicable

Detailed Description:

Intestinal organoids are 3D mini-guts produced in vitro based on intestinal stem cell (ISC) capabilities. These organoids contain all of the intestinal epithelial cells. The renewal of the two kinds of ISCs, which are present at the bottom of intestinal crypts, is controlled by Wnt/APC/beta-catenin pathway. Mutations of genes involved in this pathway are found in intestinal polyposes like familial adenomatous polyposis (FAP, APC gene).

This model is of interest to study early pathophysiological events occurring within intestinal epithelium, in the context of FAP and inflammatory bowel diseases (IBD). An excessive proliferation or an abnormal healing is found in FAP and IBD respectively. Investigators hypothesized that it could specifically involved one of the 2 ISCs. Columnar basal cells (CBC) and ISC located at the +4 position from the bottom of the crypt (ISC+4) can both differentiate into absorptive or secretory intestinal epithelial cells. However, CBC and ISC+4 could have different metabolic, migratory functions, or stress survival.

Investigators designed a monocentric pilot study to develop intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigators plan to investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC. Will also be studied the expression of key genes of tumor initiation (PTEN, BMPR1A, p53 and KRAS) and inflammatory parameters (cytokines and lipid mediators).

The results of this study could improve the understanding of intestine renewal. Later on, the development of new drugs could beneficiate to IBD and FAP patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intestinal Stem Cells Characterization in Intestinal Organoid Culture From Inflammatory Bowel Disease and Intestinal Polyposis Patients
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Crohn disorder
arm composed by 30 patients with Crohn disorder
Procedure: Endoscopic biopsies
intestinal biopsies
Experimental: FAP (familial adenomatous polyposis )
arm composed by 30 patients with FAP disorder
Procedure: Endoscopic biopsies
intestinal biopsies
Experimental: ulcerative colitis
arm composed by 30 patients with ulcerative colitis
Procedure: Endoscopic biopsies
intestinal biopsies
Sham Comparator: witness
arm composed by 30 patients with no intestinal disorders
Procedure: Endoscopic biopsies
intestinal biopsies



Primary Outcome Measures :
  1. number of organoids [ Time Frame: 2 days ]
    number of organoids in culture wells during the follow-up


Secondary Outcome Measures :
  1. mean size of organoids [ Time Frame: 2 days ]
    mean diameter of organoids in culture wells during the follow-up

  2. percentage of different types of organoids [ Time Frame: 2 days ]
    organoids are differentiated by the size of the epithelial cell border and by the presence or absence of buds



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: patient must have a coloscopy for intestinal pain -

Exclusion Criteria: cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874365


Contacts
Contact: Emmanuel MAS, MD, PhD 33 5 61 77 86 03 mas.e@chu-toulouse.fr

Locations
France
Hopital des Enfants Recruiting
Toulouse, France, 31159
Contact: Emmanuel MAS, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Emmanuel MAS, MD, PhD University Hospital, Toulouse

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02874365     History of Changes
Other Study ID Numbers: 15 7816 03
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis