Outcomes of Children With Eosinophilic Esophagitis: a Prospective Monocentric Observational Study
| Registry | NCT06190080, acronym Obs-OE |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 16 (Estimated) |
| Sponsor | Fondation Lenval (Other) |
| Conditions | Esophagitis, Eosinophilic |
| Interventions | Digestive endoscopy (Other) |
| Dates | start 2024-03-01 (estimated), primary completion 2028-03-01 (estimated), completion 2028-12-01 (estimated), first posted 2024-01-05, last updated 2024-01-16 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Esophagitis, Eosinophilic All trials of Digestive endoscopy
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Management of eosinophilic esophagitis | Other | Other: Digestive endoscopy | Follow-up visits are always organized in the same way. A consultation with a gastropediatrician will take place, with assessment of symptoms (PEESS score) and quality of life (PedsQL module for eosinophilic esophagitis and PedsQL 4.0 Generic Core Scales). Then, 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. Depending on the results, the patient may be advised to adapt or maintain the current treatment. |
Sex: All, ages: 2 Years to 17 Years
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: \-
| Facility | City | Country | Status |
|---|---|---|---|
| Hôpitaux pédiatriques de Nice CHU Lenval | Nice | France |