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Autophagy in Paediatric Crohn's Disease (P-IBDphagy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05842564
Recruitment Status : Not yet recruiting
First Posted : May 6, 2023
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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
Crohn Disease Pediatric Crohns Disease Other: Blood samples Other: Biopsies Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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
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
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Primary Outcome Measures :
  1. Quantification of autophagic flux by western blot. [ Time Frame: 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 [ Time Frame: 1 day (during hospitalization for ileocolonoscopy) ]
    DNA sequencing of polymorphisms reported in the literature as gene mutations susceptibility for Crohn's disease.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT05842564


Contacts
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Contact: Rémi DUCLAUX-LORAS, MD, PhD 0472357050 ext +33 remi.duclaux-loras@chu-lyon.fr

Locations
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France
Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL
Bron, France, 69500
Contact: Rémi DUCLAUX-LORAS, MD, PhD    0472357050 ext +33    Remi.duclaux-loras@chu-lyon.fr   
Principal Investigator: Rémi DUCLAUX-LORAS, MD, PhD         
Sub-Investigator: Nicolas CARON, MD         
Sub-Investigator: Sophie HEISSAT, MD         
Sub-Investigator: Barbara ROHMER, MD         
Sub-Investigator: Noémie LAVERDURE, MD         
Sub-Investigator: Mathias RUIZ, MD         
Sub-Investigator: Pierre POINSOT, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT05842564    
Other Study ID Numbers: 69HCL21_1020
First Posted: May 6, 2023    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Crohn's Disease
Autophagy
Polymorphism
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases