Outcome of Children With Eosinophilic Esophagitis

NCT06190080 | Not Yet Recruiting

• 1 other identifier: 23-HPNCL-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Esophagitis, Eosinophilic

Keywords

children; eosinophilic esophagitis; life quality

Outcome Measures

Primary Outcomes (1)

• Determine the rate of complete remission

  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

  at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.

Secondary Outcomes (2)

• Description at inclusion of a cohort of pediatric patients with OE

  throught a 24 months follow-up

• evolution of quality of life

  at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment

Study Arms (1)

Management of eosinophilic esophagitis

OTHER

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.

Other: Digestive endoscopy

Interventions

Digestive endoscopy 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.

Management of eosinophilic esophagitis

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux pédiatriques de Nice CHU Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Mathilde Butori Pepino, MD

CONTACT

04.92.03.10.12; mathilde.butori@hpu.lenval.com

Marion Mouchet

CONTACT

marion6.mouchet@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2024

Record last verified: 2023-12

Locations

FR (1)