NCT05842564Not yet recruiting
Autophagy in Paediatric Crohn's Disease
Autophagic Activity Characterization in Pediatric Crohn's Disease
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 24 Apr 2023
- Start date
- Jan 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Crohn's disease
- NCT number
- NCT05842564
What you commit to
- Study type: Interventional
- Planned participants: 70
- From Jan 2025 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Intercurrent infection
- Persons subject to psychiatric care
Other
- Refusal to participate in the protocol
- 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 admitted to a health or social establishment for purposes other than research
Who the study is looking for
- 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.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL Coordinator of this site? Confirm its status | Bron | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.