Outcome of Children With Eosinophilic Esophagitis

Not Applicable

Not yet recruiting

• Conditions: Esophagitis, Eosinophilic

• Registration Number: NCT06190080
• Lead Sponsor: Fondation Lenval

Brief Summary

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Study Start: 2024-03
• Primary Completion: 2028-03
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the rate of complete remission	at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.	Complete remission will be defined according to the following criteria: 1. Abolition of clinical symptoms as assessed by the Pediatric Eosinophilic Esophagitis Symptom Score; 2. Endoscopic score: EoE Endoscopic Reference Score (EREFS) ≤ 2 in the lower, middle and upper thirds of the esophagus.; 3. Eosinophilic infiltrate \< 5/HPF in standard HES (Haemato-Eosin-Safran) stain on biopsies from lower, middle and upper thirds of esophagus; 4. No therapeutic change at follow-up visit to assess remission

Secondary Outcome Measures

Name	Time	Method
evolution of quality of life	at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment	Quality of life will be measured using the Pediatric Quality of Life Questionnaire (PedsQL Eosinophilic Esophagitis part ) currently being validated in French by our team.; The PedsQL eosinophilic eosophagitis module is divided into several forms, each corresponding to different age groups with questions adapted according to age. (2-4 years, 5-7 years, 8-12 years and 13-18 years). This questionnaire is intended for children and their parents.; The total score is the sum of the 35 items for 8-17 year olds, 22 for 2-4 year olds, 27 for 5-7 year olds. The maximum score is 175 for 8-17 year olds, 110 for 2-4 year olds, 135 for 5-7 year olds. The higher the score, the greater the impact of eosinophilic esophagitis on the patient's life.; Nevertheless, we will also use a more general quality-of-life questionnaire, the PedsQL 4.0 Generic Core Scales in its French version.
Description at inclusion of a cohort of pediatric patients with OE	throught a 24 months follow-up	The description of the population will be carried out at baseline and during a 24 months follow-up at each consultation (M3, M6, M12, M18 and M24) by the patient's referring physician, listing : * demographic (age, gender, lifestyle) and medical (history, allergies, etc.) data at baseline only; * Clinical data (types of symptoms, possible complications, etc.); * Paraclinical data (endoscopic and anapathic scores at diagnosis)

Trial Locations

Locations (1)

Hôpitaux pédiatriques de Nice CHU Lenval; 🇫🇷 Nice, France