Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190080
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-12-19
Brief Title:
Outcome of Children With Eosinophilic Esophagitis
Sponsor:
Fondation Lenval
Organization:
Fondation Lenval
Study Overview
Official Title:
Outcomes of Children With Eosinophilic Esophagitis a Prospective Monocentric Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Obs-OE
Brief Summary:
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
This study would also enable us to investigate the quality of life of these chronically ill patients
Detailed Description:
The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission clinical endoscopic and histological at 3 months 6 months 12 months 18 months and 24 months of treatment initiation It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up and to study their quality of life
Follow-up visits is organized every 3 months with a gastropediatrician who assesses the patients symptoms PEESS score and quality of life PedsQL eosinophilic esophagitis module and PedsQL 40 Generic Core Scales
If treatment needs to be introduced or changed a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not
Follow-up visits is organized every 3 months with a gastropediatrician who assesses the patients symptoms PEESS score and quality of life PedsQL eosinophilic esophagitis module and PedsQL 40 Generic Core Scales
If treatment needs to be introduced or changed a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None