Outcome of Children With Eosinophilic Esophagitis
ConditionEsophagitis, Eosinophilic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorFondation Lenval
About this trial
The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months.
This study would also enable us to investigate the quality of life of these chronically ill patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of OE according to the diagnostic criteria of the PNDS published in July 2022
Due to start treatment.
informed consent from one of the 2 parents or the representative of parental authority.
Membership of a social security scheme.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Digestive endoscopy
Other interventionDigestive endoscopies are performed in the operative room under general anaesthetic 3 months after the introduction or change of treatment. Biopsies of the upper, middle and lower thirds of the esophagus will be taken and analyzed for pathology.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Management of eosinophilic esophagitisOther 1 intervention
Trial outcomes
Primary outcomes
1
Determine the rate of complete remission
Complete remission will be defined according to the following criteria: 1. Abolition of clinical symptoms as assessed by the Pediatric Eosinophilic Esophagitis Symptom Score 2. Endoscopic score: EoE Endoscopic Reference Score (EREFS) ≤ 2 in the lower, middle and upper thirds of the esophagus. 3. Eosinophilic infiltrate \< 5/HPF in standard HES (Haemato-Eosin-Safran) stain on biopsies from lower, middle and upper thirds of esophagus 4. No therapeutic change at follow-up visit to assess remission
Time frame
at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.Secondary outcomes
1
Description at inclusion of a cohort of pediatric patients with OE
The description of the population will be carried out at baseline and during a 24 months follow-up at each consultation (M3, M6, M12, M18 and M24) by the patient's referring physician, listing : * demographic (age, gender, lifestyle) and medical (history, allergies, etc.) data at baseline only * Clinical data (types of symptoms, possible complications, etc.) * Paraclinical data (endoscopic and anapathic scores at diagnosis)
Time frame
throught a 24 months follow-up2
evolution of quality of life
Quality of life will be measured using the Pediatric Quality of Life Questionnaire (PedsQL Eosinophilic Esophagitis part ) currently being validated in French by our team. 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. Nevertheless, we will also use a more general quality-of-life questionnaire, the PedsQL 4.0 Generic Core Scales in its French version.
Time frame
at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: