Outcome of Children With Eosinophilic Esophagitis

NCT ID: NCT06190080

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Esophagitis, Eosinophilic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Management of eosinophilic esophagitis

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.

Group Type OTHER

Digestive endoscopy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Lenval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux pédiatriques de Nice CHU Lenval

Nice, , France

Site Status

Countries

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France

Central Contacts

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Mathilde Butori Pepino, MD

Role: CONTACT

04.92.03.10.12

Marion Mouchet

Role: CONTACT

Facility Contacts

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Mathilde Butori Pepino, MD

Role: primary

04.92.03.10.12

Marion Mouchet

Role: backup

Other Identifiers

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23-HPNCL-05

Identifier Type: -

Identifier Source: org_study_id

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