Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05900011
Study type Observational
Source Fondation Lenval
Contact Olivier COURBETTE, MD
Phone 04 92 03 05 65
Email olivier.courbette@hpu.lenval.com
Status Recruiting
Phase
Start date July 17, 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT03382678 - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Completed NCT05083312 - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial Phase 3
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Terminated NCT02314455 - Esophageal Absorption in EoE N/A
Completed NCT01953575 - Mucosal Impedance and Eosinophilic Esophagitis N/A
Completed NCT01386112 - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis Phase 1/Phase 2
Recruiting NCT04991935 - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis Phase 3
Not yet recruiting NCT05896891 - San Raffaele EoE Biobank
Active, not recruiting NCT05482256 - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis N/A
Recruiting NCT05485155 - Zemaira Eosinophilic Esophagitis Pilot Study Phase 2
Recruiting NCT04149470 - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) Phase 4
Recruiting NCT04416217 - Eosinophilic Esophagitis Steroid Safety Study
Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population