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Starting soon Not applicable

Autophagy in Paediatric Crohn's Disease

NCT05842564 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-01
Last updated
2024-12-12

Condition(s) studied

Crohn DiseasePediatric Crohns Disease

Investigational drug(s) / intervention(s)

Blood samplesBiopsies

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

Study 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

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL Bron France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05842564 on ClinicalTrials.gov ↗ ← All trials in France