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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

For children :
  • - 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:

- Intellectual disability, cognitive inability to complete the questionnaire

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05900011
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondation Lenval
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Additional Details

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.

Arms & Interventions

Arms

: Patients in the pediatric population with eosinophilic eosphagitis

Patients in the pediatric population with eosinophilic eosiphagitis responding to the PedsQL eosinophilic eosophagitis module

Interventions

Behavioral: - Quality of life questionnaire

Measurement of the quality of life of patients with eosinophilic esophagitis by the PedsQL questionnaire eosinophilic esophagitis module

Contact a Trial Team

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International Sites

Hopitaux Pediatriques de Nice Chu-Lenval, Nice, France

Status

Recruiting

Address

Hopitaux Pediatriques de Nice Chu-Lenval

Nice, ,

Site Contact

Olivier Courbette, MD

[email protected]

04 92 03 05 65

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