Outcome of Children With Eosinophilic Esophagitis (Obs-OE)

Fondation Lenval

Status: Not yet enrolling

Conditions: Esophagitis, Eosinophilic

Treatments: Other: Digestive endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06190080

23-HPNCL-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Management of eosinophilic esophagitis

Other group

Description:

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.

Treatment:

Other: Digestive endoscopy