P-IBDphagy: Autophagy in Paediatric Crohn's Disease

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05842564
Collaborator
(none)
70
1
2
27
2.6

Study Details

Study Description

Brief Summary

Crohn's disease is a multifactorial complex disease resulting in a between microbiota and immune system. Indeed, GWAS (Genome-Wide Association Studies) association study pinpointed polymorphisms as genes susceptibility on more than 200 loci. Among them genes coding for proteins involved in autophagy machinery (i.e: ATG16L1, IRGM et NDP52). Autophagy is a ubiquitous intracellular mechanism mandatory for protein and microorganism recycling.

So far, the role of autophagy in gut inflammation and intestinal homeostasis in Crohn's disease patients is partially understand. Then, investigators plan to evaluate, on native cells, the autophagic flux in pediatric patients suffering of a Crohn's disease compare to controls.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood samples
  • Other: Biopsies
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Autophagic Activity Characterization in Pediatric Crohn's Disease
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Crohn's Disease Group

Patients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old.

Other: Blood samples
Blood sample of maximum 20ml (5 tubes of EDTA of 4ml or 5 tubes of EDTA of 2ml and a tube for the conservation of genomic DNA)

Other: Biopsies
5 biopsies (one for each segment of the intestine explored: ileum, right colon, transverse colon left colon and sigmoid) will be taken during the ileocolonoscopy

Other: Control Group

Patients followed for functional abdominal disorders

Other: Blood samples
Blood sample of maximum 20ml (5 tubes of EDTA of 4ml or 5 tubes of EDTA of 2ml and a tube for the conservation of genomic DNA)

Other: Biopsies
5 biopsies (one for each segment of the intestine explored: ileum, right colon, transverse colon left colon and sigmoid) will be taken during the ileocolonoscopy

Outcome Measures

Primary Outcome Measures

  1. Quantification of autophagic flux by western blot. [1 day (during hospitalization for ileocolonoscopy)]

    LC3II/LC3I will be measured by western blot after booking the autophagic flux at different time point.

Secondary Outcome Measures

  1. Incidence of autophagic polymorphisms in pediatric Crohn's disease population [1 day (during hospitalization for ileocolonoscopy)]

    DNA sequencing of polymorphisms reported in the literature as gene mutations susceptibility for Crohn's disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
For Crohn's Disease group :
  • Age between 6 and 17 inclusive

  • Patients with a weight > 25 kg at the time of inclusion

  • Patients with Crohn's disease requiring ileocolonoscopy (diagnosis or follow-up)

  • Mild to severe Crohn's disease consistent with PCDAI disease activity score

  • Patients on nutritional therapy (Modulen/Modulife), corticosteroids, salicylic derivatives, immunosuppressants, biotherapies (anti-TNF, vedolizumab and ustekinumab) or without treatment

  • Consent form signed by the patient or the holder(s) of parental authority.

  • Affiliation to a social security scheme or beneficiaries of a similar scheme.

For Control group:
  • Between 6 and 17 years old included

  • Presenting a weight > 25 kg at the time of inclusion

  • Without a diagnosis of Crohn's disease

  • Requiring evaluation by ileoendoscopy

  • Consent form signed by the patient or the holder(s) of parental authority.

  • Affiliation to a social security scheme or beneficiaries of a similar scheme.

Exclusion Criteria:
  • Refusal to participate in the protocol

  • Intercurrent infection

  • Ongoing antibiotic treatment

  • Patient involved in another interventional study protocol including an exclusion period still in progress at pre-inclusion

  • Pregnant, parturient or breastfeeding women (on questioning)

  • Persons deprived of their liberty by a judicial or administrative decision

  • Persons subject to psychiatric care

  • Persons admitted to a health or social establishment for purposes other than research

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05842564
Other Study ID Numbers:
  • 69HCL21_1020
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023