Autophagy in Paediatric Crohn's Disease

NCT05842564 | Not Yet Recruiting

• 1 other identifier: 69HCL21_1020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Pediatric Crohns Disease

Keywords

Crohn's Disease; Autophagy; Polymorphism

Outcome Measures

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.

  1 day (during hospitalization for ileocolonoscopy)

Secondary Outcomes (1)

• Incidence of autophagic polymorphisms in pediatric Crohn's disease population

  1 day (during hospitalization for ileocolonoscopy)

Study Arms (2)

Crohn's Disease Group

EXPERIMENTAL

Patients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old.

Other: Blood samples; Other: Biopsies

Control Group

OTHER

Patients followed for functional abdominal disorders

Other: Blood samples; Other: Biopsies

Interventions

Blood samples OTHER

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)

Control Group; Crohn's Disease Group

Biopsies OTHER

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

Control Group; Crohn's Disease Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For Crohn's Disease group :
• Age between 6 and 17 inclusive
• 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
• 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.

You may not qualify if:

• Refusal to participate in the protocol
• Intercurrent infection
• Ongoing antibiotic treatment
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL

Bron, 69500, France

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Blood Specimen Collection; Biopsy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Central Study Contacts

Rémi DUCLAUX-LORAS, MD, PhD

CONTACT

0472357050; remi.duclaux-loras@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)