Outcome of Children With Eosinophilic Esophagitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digestive endoscopy.
- Who it may be relevant to
- Registry conditions: Esophagitis, Eosinophilic. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Outcomes of Children With Eosinophilic Esophagitis: a Prospective Monocentric Observational Study
Overview
The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months. This study would also enable us to investigate the quality of life of these chronically ill patients
Detailed description
The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up, and to study their quality of life.
Follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 Generic Core Scales).
If treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.
Interventions
- Other Digestive endoscopy
Digestive endoscopies are performed in the operative room under general anaesthetic 3 months after the introduction or change of treatment. Biopsies of the upper, middle and lower thirds of the esophagus will be taken and analyzed for pathology.
Primary outcome measures
- Determine the rate of complete remission [Time frame: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.]
Secondary outcome measures (2)
- Description at inclusion of a cohort of pediatric patients with OE [Time frame: throught a 24 months follow-up]
- evolution of quality of life [Time frame: at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment]
Eligibility criteria
Inclusion criteria
- Diagnosis of OE according to the diagnostic criteria of the PNDS published in July 2022
- Due to start treatment.
- informed consent from one of the 2 parents or the representative of parental authority.
- Membership of a social security scheme.
Exclusion criteria
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hôpitaux pédiatriques de Nice CHU Lenval — Nice
Identifiers
NCT: NCT06190080 · 23-HPNCL-05