NCT05900011

Validation in French of a Quality of Life Questionnaire for Patients With Eosinophilic Esophagitis in Pediatrics

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondation Lenval · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Eosinophilic esophagitis is a chronic condition of the esophagus. The symptoms of eosinophilic esophagitis can affect the quality of life of affected children. There is no French scale to specifically evaluate the quality of life of these patients. It will be a monocentric, prospective, descriptive study carried out at the Nice University Pédiatric Hospital. The main objective of this study will be the validation of a French version of the quality of life pediatric scale (PedsQL) module for eosinophilic esophagitis. It will take place in 2 distinct parts: * The translation of the questionnaire in French. * Collection of the quality of life questionnaires

Detailed description

Eosinophilic esophagitis is a chronic pathology of the esophagus. It is the most prevalent condition of chronic esophagitis after gastroesophageal reflux and the largest cause of dysphagia and food impaction in children. Currently the explosion of incidence of cases in the world makes eosinophilic esophagitis a public health issue and a scientific challenge. In pediatrics, the main symptoms are: dysphagia, feeding difficulties, pyrosis, but also more general symptoms such as: nausea, vomiting or growth retardation. The diagnosis of eosinophilic eosophagitis is mainly made in pathological anatomy on esophageal biopsies. Current recommendations suggest that two to four biopsies should be taken at two different levels (proximal and distal esophagus if possible), even in cases of apparently normal mucosa. The presence of an infiltration of the esophageal mucosa greater than 15 eosinophils per field is mandatory for the diagnosis. In total, the diagnosis is therefore based on anamnestic and histological elements and the absence of other pathology. Recent French recommendations have led to a consensus on the management of this disease. The therapeutic goal is to achieve clinical and histological remission. Three therapies are currently proposed to patients: proton pump inhibitors, corticosteroids and exclusion diet. The drug treatments used are treatments that have been known for a long time but there is no study that has shown the superiority of one over the other. Symptoms of eosinophilic esophagitis can affect the quality of life of affected children and their caregivers. The quality of life pediatric scale (PedsQL ) Modulates Eosinophilic Esophagitis is a validated, American scale that specifically assesses the quality of life of patients with eosinophilic esophagitis in the pediatric population. There is no French scale to specifically assess the quality of life of patients with eosinophilic esophagitis in the pediatric population. The aim of this study is to validate a French and cross-cultural version of the PedsQL quality of life scale for EoE in pediatrics. It will be a monocentric, prospective, descriptive study carried out at the Nice University Pediatric Hospital.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
BEHAVIORAL	Quality of life questionnaire	Measurement of the quality of life of patients with eosinophilic esophagitis by the PedsQL questionnaire eosinophilic esophagitis module

Timeline

• Start date: 2023-07-17
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2023-06-12
• Last updated: 2023-09-29

Locations

1 site across 1 country: France