Validation in French of a Quality of Life Questionnaire for Patients With Eosinophilic Esophagitis in Pediatrics
NCT ID: NCT05900011
Last Updated: 2023-09-29
Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2023-07-17
2024-12-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients in the pediatric population with eosinophilic eosphagitis
Patients in the pediatric population with eosinophilic eosiphagitis responding to the PedsQL eosinophilic eosophagitis module
Quality of life questionnaire
Measurement of the quality of life of patients with eosinophilic esophagitis by the PedsQL questionnaire eosinophilic esophagitis module
Interventions
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Quality of life questionnaire
Measurement of the quality of life of patients with eosinophilic esophagitis by the PedsQL questionnaire eosinophilic esophagitis module
Eligibility Criteria
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Inclusion Criteria
* Patients followed at Nice-Lenval University Hospital in pediatric gastroenterology between July 2022 and July 2023
* Age between 2 and 17 years old
* Obligation for all patients to be affiliated to social security system
* Patient followed for eosinophilic esophagitis. Diagnostic criteria for EoE ( compatible symptoms and histological involvement on at least two different esophageal levels: presence of infiltration of the esophageal mucosa greater than 15 eosinophils per field)
* Acceptance of participation in the study
For parents or representative of parental authority:
* Parents or representative of parental authority, of a child followed at Lenval Hospital in pediatric gastroenterology for eosinophilic esophagitis
* Affiliated to a social security system
* Acceptance of participation in the study
Exclusion Criteria
2 Years
17 Years
ALL
No
Sponsors
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Fondation Lenval
OTHER
Responsible Party
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Locations
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Hopitaux Pediatriques de Nice Chu-Lenval
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-HPNCL-01
Identifier Type: -
Identifier Source: org_study_id
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