Autophagy in Paediatric Crohn's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorHospices Civils de Lyon
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Blood samples
Other interventionBlood 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
Other intervention5 biopsies (one for each segment of the intestine explored: ileum, right colon, transverse colon left colon and sigmoid) will be taken during the ileocolonoscopy
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Crohn's Disease GroupExperimental treatment 2 interventions
Group B: Control GroupOther 2 interventions
Trial outcomes
Primary outcomes
1
Quantification of autophagic flux by western blot.
LC3II/LC3I will be measured by western blot after booking the autophagic flux at different time point.
Time frame
1 day (during hospitalization for ileocolonoscopy)Secondary outcomes
1
Incidence of autophagic polymorphisms in pediatric Crohn's disease population
DNA sequencing of polymorphisms reported in the literature as gene mutations susceptibility for Crohn's disease.
Time frame
1 day (during hospitalization for ileocolonoscopy)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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