Crohn DiseaseP-IBDphagyNCT05842564
Autophagy in Paediatric Crohn's Disease
A study testing Blood samples and Biopsies in people with Crohn Disease and Pediatric Crohns Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Crohn Disease, Pediatric Crohns Disease
- What is being tested?
- Blood samples and Biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service Hépatologie, Gastroentérologie et Nutrition pédiatrique, Hôpital Femme Mère Enfant, HCL
Bron, 69500
Rémi DUCLAUX-LORAS, MD, PhD, 0472357050 ext. +33, Remi.duclaux-loras@chu-lyon.fr
Rémi DUCLAUX-LORAS, MD, PhD
About this study
Official title: Autophagic Activity Characterization in Pediatric 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.
- Conditions
- Crohn Disease, Pediatric Crohns Disease
- Being tested
- Blood samples, Biopsies
- Keywords
- Crohn's Disease, Autophagy, Polymorphism
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
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)
BiopsiesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease Group | Experimental | Patients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old. Receives: Other: Blood samples; Other: Biopsies |
| Control Group | Other | Patients followed for functional abdominal disorders Receives: Other: Blood samples; Other: Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of autophagic flux by western blot.
LC3II/LC3I will be measured by western blot after booking the autophagic flux at different time point.
Measured: 1 day (during hospitalization for ileocolonoscopy)
Secondary outcomes (1)
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.
Measured: 1 day (during hospitalization for ileocolonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startJan 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842564
- Sponsor's protocol ID
- 69HCL21_1020
- Acronym
- P-IBDphagy
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autophagic Activity Characterization in Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT05842564
- Acronym / sponsor ID
- P-IBDphagy / 69HCL21_1020
- Conditions
- Crohn Disease, Pediatric Crohns Disease
- Keywords
- Crohn's Disease, Autophagy, Polymorphism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease Group | Experimental | Other: Blood samples, Other: BiopsiesPatients followed for a Crohn's Disease in consultation or in day hospital aged between 6 and 18 years old. |
| Control Group | Other | Other: Blood samples, Other: BiopsiesPatients followed for functional abdominal disorders |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood 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) | Other | Control Group, Crohn's Disease Group |
| Biopsies5 biopsies (one for each segment of the intestine explored: ileum, right colon, transverse colon left colon and sigmoid) will be taken during the ileocolonoscopy | Other | Control Group, Crohn's Disease Group |
Primary outcome
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.
1 secondary outcome
Incidence of autophagic polymorphisms in pediatric Crohn's disease population
Time frame: 1 day (during hospitalization for ileocolonoscopy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples and Biopsies in people with Crohn Disease and Pediatric Crohns Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rémi DUCLAUX-LORAS, MD, PhD (0472357050 ext. +33, remi.duclaux-loras@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of autophagic flux by western blot. (time frame: 1 day (during hospitalization for ileocolonoscopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.