Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2025-01-31
2027-04-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Study Groups
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Crohn's Disease Group
Patients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old.
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)
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
Control Group
Patients followed for functional abdominal disorders
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)
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
Interventions
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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)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
17 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Rémi DUCLAUX-LORAS, MD, PhD
Role: primary
Other Identifiers
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69HCL21_1020
Identifier Type: -
Identifier Source: org_study_id