Autophagy in Paediatric Crohn's Disease (P-IBDphagy)

• ClinicalTrials.gov Identifier: NCT05842564
• Recruitment Status: Not yet recruiting
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Tracking Information

• First Submitted Date: April 24, 2023
• First Posted Date: May 6, 2023
• Last Update Posted Date: May 6, 2023
• Estimated Study Start Date: June 2023
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2023)

Quantification of autophagic flux by western blot. [ Time Frame: 1 day (during hospitalization for ileocolonoscopy) ]

LC3II/LC3I will be measured by western blot after booking the autophagic flux at different time point.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 24, 2023)

Incidence of autophagic polymorphisms in pediatric Crohn's disease population [ Time Frame: 1 day (during hospitalization for ileocolonoscopy) ]

DNA sequencing of polymorphisms reported in the literature as gene mutations susceptibility for Crohn's disease.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Autophagy in Paediatric Crohn's Disease
• Official Title: Autophagic Activity Characterization in Pediatric Crohn's Disease

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Basic Science

Condition

• Crohn Disease
• Pediatric Crohns Disease

Intervention

• 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

Study Arms

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

  • Other: Blood samples
  • Other: Biopsies
• Control Group
  Patients followed for functional abdominal disorders
  Interventions:

  • Other: Blood samples
  • Other: Biopsies

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 24, 2023): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2025
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Rémi DUCLAUX-LORAS, MD, PhD; 0472357050 ext +33; remi.duclaux-loras@chu-lyon.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05842564
• Other Study ID Numbers: 69HCL21_1020
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hospices Civils de Lyon
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospices Civils de Lyon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospices Civils de Lyon
• Verification Date: April 2023