Autophagy in Paediatric Crohn's Disease

Crohn Disease Clinical Trial

— P-IBDphagy  

Official title:

Autophagic Activity Characterization in Pediatric Crohn's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05842564
• Other study ID #: 69HCL21_1020
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2023
• Source: Hospices Civils de Lyon
• Contact: Rémi DUCLAUX-LORAS, MD, PhD
• Phone: 0472357050
• Email: remi.duclaux-loras[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Pediatric Crohns Disease

Intervention

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)
• 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

Locations

Country	Name	City	State
France	Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of autophagic flux by western blot.	LC3II/LC3I will be measured by western blot after booking the autophagic flux at different time point.	1 day (during hospitalization for ileocolonoscopy)
Secondary	Incidence of autophagic polymorphisms in pediatric Crohn's disease population	DNA sequencing of polymorphisms reported in the literature as gene mutations susceptibility for Crohn's disease.	1 day (during hospitalization for ileocolonoscopy)