Menu
Not yet recruiting NCT05842564

Autophagy in Paediatric Crohn's Disease

No phase Interventional Crohn Disease Pediatric Crohns Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples, Biopsies.
Who it may be relevant to
Registry conditions: Crohn Disease, Pediatric Crohns Disease. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autophagic Activity Characterization in Pediatric Crohn's Disease

Overview

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.

Interventions

  • 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)
  • Other 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

Primary outcome measures

  • Quantification of autophagic flux by western blot. [Time frame: 1 day (during hospitalization for ileocolonoscopy)]
Secondary outcome measures (1)
  • Incidence of autophagic polymorphisms in pediatric Crohn's disease population [Time frame: 1 day (during hospitalization for ileocolonoscopy)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Single blind
Primary purpose
Basic science

Study locations

France · 1 center
  • Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant — Bron

Identifiers

NCT: NCT05842564 · 69HCL21_1020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗