An observational study in Eosinophilic Esophagitis, sponsored by Fondation Lenval. Recruiting at 1 site in France. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Fondation Lenval · Observational
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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:
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.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients in the pediatric population with eosinophilic eosiphagitis responding to the PedsQL eosinophilic eosophagitis module and their parents
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For children :
For parents or representative of parental authority:
Exclusion Criteria:
Patients in the pediatric population with eosinophilic eosiphagitis responding to the PedsQL eosinophilic eosophagitis module
Behavioral: Quality of life questionnaire
Measurement of the quality of life of patients with eosinophilic esophagitis by the PedsQL questionnaire eosinophilic esophagitis module
Measure of quality of life
Validation of a French and cross-cultural version of the quality of life scale for eosinophilic esophagitis in pediatrics (PedsQL) 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.
Time frame: at inclusion
reliability of the interviewer
Evaluation of the reliability of the interviewer and reliability over time. An evaluation of the structure will be conducted. Sensitivity to change of the questionnaire will be assessed
Time frame: through study completion, an average of 1 year
Started Jul 2023 (actual). Primary completion is estimated for Jul 2024, 12 months after the start.
Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 12 months is below that.
Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
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Fondation Lenval