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NCT Number: NCT05842564

Autophagy in Paediatric Crohn's Disease

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pediatric Crohns Disease

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bron, 69500, France

Location contact

Barbara ROHMER, MD

SUB_INVESTIGATOR

Mathias RUIZ, MD

SUB_INVESTIGATOR

Nicolas CARON, MD

SUB_INVESTIGATOR

Noémie LAVERDURE, MD

SUB_INVESTIGATOR

Pierre POINSOT, MD

SUB_INVESTIGATOR

Rémi DUCLAUX-LORAS, MD, PhD

CONTACT

[email protected]

0472357050 ext. +33

Rémi DUCLAUX-LORAS, MD, PhD

PRINCIPAL_INVESTIGATOR

Sophie HEISSAT, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rémi DUCLAUX-LORAS, MD, PhD

CONTACT

[email protected]

0472357050 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Autophagic Activity Characterization in Pediatric Crohn's Disease

Acronym: P-IBDphagy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 6, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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