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Autophagy in Paediatric Crohn's Disease

Autophagic Activity Characterization in Pediatric Crohn's Disease

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05842564
Acronym
P-IBDphagy
Enrollment
70
Registered
2023-05-06
Start date
2025-01-31
Completion date
2027-04-30
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Pediatric Crohns Disease

Keywords

Crohn's Disease, Autophagy, Polymorphism

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.

Interventions

OTHERBlood 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)

OTHERBiopsies

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Incidence of autophagic polymorphisms in pediatric Crohn's disease population1 day (during hospitalization for ileocolonoscopy)DNA sequencing of polymorphisms reported in the literature as gene mutations susceptibility for Crohn's disease.

Countries

France

Contacts

Primary ContactRémi DUCLAUX-LORAS, MD, PhD
remi.duclaux-loras@chu-lyon.fr0472357050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026