Autophagy in Paediatric Crohn's Disease
- Conditions
- Crohn DiseasePediatric Crohns Disease
- Interventions
- Other: Blood samplesOther: Biopsies
- Registration Number
- NCT05842564
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Crohn's Disease Group Blood samples Patients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old. Crohn's Disease Group Biopsies Patients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old. Control Group Biopsies Patients followed for functional abdominal disorders Control Group Blood samples Patients followed for functional abdominal disorders
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL
🇫🇷Bron, France