search
Back to results

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

Primary Purpose

Crohn Disease, Pediatric Crohns Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Biopsies
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Crohn Disease focused on measuring Crohn's Disease, Autophagy, Polymorphism

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Crohn's Disease Group

Control Group

Arm Description

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

Patients followed for functional abdominal disorders

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 24, 2023
Last Updated
April 24, 2023
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT05842564
Brief Title
Autophagy in Paediatric Crohn's Disease
Acronym
P-IBDphagy
Official Title
Autophagic Activity Characterization in Pediatric Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Pediatric Crohns Disease
Keywords
Crohn's Disease, Autophagy, Polymorphism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crohn's Disease Group
Arm Type
Experimental
Arm Description
Patients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old.
Arm Title
Control Group
Arm Type
Other
Arm Description
Patients followed for functional abdominal disorders
Intervention Type
Other
Intervention Name(s)
Blood samples
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Biopsies
Intervention Description
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 Outcome Measure Information:
Title
Quantification of autophagic flux by western blot.
Description
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 Outcome Measure Information:
Title
Incidence of autophagic polymorphisms in pediatric Crohn's disease population
Description
DNA sequencing of polymorphisms reported in the literature as gene mutations susceptibility for Crohn's disease.
Time Frame
1 day (during hospitalization for ileocolonoscopy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rémi DUCLAUX-LORAS, MD, PhD
Phone
0472357050
Ext
+33
Email
remi.duclaux-loras@chu-lyon.fr
Facility Information:
Facility Name
Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémi DUCLAUX-LORAS, MD, PhD
Phone
0472357050
Ext
+33
Email
Remi.duclaux-loras@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Rémi DUCLAUX-LORAS, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nicolas CARON, MD
First Name & Middle Initial & Last Name & Degree
Sophie HEISSAT, MD
First Name & Middle Initial & Last Name & Degree
Barbara ROHMER, MD
First Name & Middle Initial & Last Name & Degree
Noémie LAVERDURE, MD
First Name & Middle Initial & Last Name & Degree
Mathias RUIZ, MD
First Name & Middle Initial & Last Name & Degree
Pierre POINSOT, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Autophagy in Paediatric Crohn's Disease

We'll reach out to this number within 24 hrs