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

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Pediatric Crohns Disease; Crohn Disease

Treatments: Other: Biopsies; Other: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT05842564

69HCL21_1020

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Crohn's Disease Group

Experimental group

Description:

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

Treatment:

Other: Blood samples

Other: Biopsies

Control Group

Other group

Description:

Patients followed for functional abdominal disorders

Treatment:

Other: Blood samples

Other: Biopsies