Autophagy in Paediatric Crohn's Disease
Not applicable · Testing Blood samples and Biopsies · 1 site · Hospices Civils de Lyon
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Blood samples and Biopsies to better understand how the disease works. Condition(s) listed: Crohn Disease and Pediatric Crohns Disease.
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 6 to 17
- Any sex
Some of the main requirements, copied from the record:
- For Crohn's Disease group :
- Age between 6 and 17 inclusive
- Patients with a weight > 25 kg at the time of inclusion
Plus 12 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2025-01 (planned).
- Main results expected around 2027-04 (estimate from the record).
- 1 study site listed in France.
Main thing being measured
- Quantification of autophagic flux by western blot. (1 day (during hospitalization for ileocolonoscopy))
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Pediatric Crohns Disease |
| Lead sponsor | Hospices Civils de Lyon |
| Enrollment | 70 (estimated) |
| Start date | 2025-01 |
| Primary completion (est.) | 2027-04 |
| First posted | 2023-05-06 |
| Last updated | 2024-12-12 |
| Official title | Autophagic Activity Characterization in Pediatric Crohn's Disease |
| ClinicalTrials.gov ID | NCT05842564 |
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) - 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
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL | Bron | France |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.