Clinical trial NCT05842564: Autophagy in Paediatric Crohn's Disease
Official title: Autophagic Activity Characterization in Pediatric Crohn's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Pediatric Crohns Disease
Keywords: Crohn's Disease
Autophagy
Polymorphism
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Quantification of autophagic flux by western blot.
timeFrame: 1 day (during hospitalization for ileocolonoscopy)
Secondary outcomes:
measure: Incidence of autophagic polymorphisms in pediatric Crohn's disease population
timeFrame: 1 day (during hospitalization for ileocolonoscopy)
Other outcomes:
Locations:
city: Bron
country: France
facility: Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL
Study officials:
References: