Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381219
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-12-19
Brief Title:
Pediatric Eosinophilic Esophagitis pedEoE Effect of Allergen Heat Denaturation on EoE Remission a Pilot Trial
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Pediatric Eosinophilic Esophagitis pedEoE Effect of Allergen Heat Denaturation on EoE Remission a Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The objective of the study is to study whether the introduction of heated food products more specifically heated hens egg andor cows milk in children with EoE would be possible without re-occurrence of the eosinophilic inflammation while the intake of less heated products might cause disease recidive Moreover we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated could lead to tolerance induction in EoE
Detailed Description:
If inclusion criteria are met after obtaining informed consent from the parents and when old enough assent from the children children with cows milk andor hens egg induced pedEoE will be included in this pilot trial Baseline blood will be obtained before in-house OFC procedure and serum will be stored for specific IgG4 analysis In parallel PBMCs will be isolated and stimulated in vitro with heat denatured proteins B cells will be stained by 4-laserflow cytometry IgG4 production in supernatants will be studied by ELISA specific IgG4 by Immunocap 100 This procedure will be repeated during each gastroscopy
Children will be provoked in-house based on the written procedure available for heated egg or cows milk provocation Afterwards they will introduce heated egg by cake or 20 boiled cows milk at least three times a week for 8 weeks and will return to the hospital for a gastroscopy with biopsies EoE remission will be studied on biopsies of the upper and lower esophagus by eosinophil staining within the routine anatomopathological laboratory within our hospital
If remission remains subjects will be invited to introduce less heated hens egg or cows milk for 8 weeks after which they will return to the hospital for the second gastroscopy with similar procedure This is repeated three times until 4 soft-boiled egg or 5 boiled cows milk is introduced for 8 weeks When remission remains after this introduction the children and parents are offered the possibility to terminate the study or to introduce either raw egg tiramisu or chocolate mousse or uncooked UHT-treated cows milk for 8 weeks after which gastroscopy with biopsies will be performed
If remission is lost they will return to the strict avoidance diet for at least 10 weeks after which they will return to the hospital for their second gastroscopy Upon remission after avoidance the children will remain eligible for another heat denatured food challenge when on diet for both
Children will be provoked in-house based on the written procedure available for heated egg or cows milk provocation Afterwards they will introduce heated egg by cake or 20 boiled cows milk at least three times a week for 8 weeks and will return to the hospital for a gastroscopy with biopsies EoE remission will be studied on biopsies of the upper and lower esophagus by eosinophil staining within the routine anatomopathological laboratory within our hospital
If remission remains subjects will be invited to introduce less heated hens egg or cows milk for 8 weeks after which they will return to the hospital for the second gastroscopy with similar procedure This is repeated three times until 4 soft-boiled egg or 5 boiled cows milk is introduced for 8 weeks When remission remains after this introduction the children and parents are offered the possibility to terminate the study or to introduce either raw egg tiramisu or chocolate mousse or uncooked UHT-treated cows milk for 8 weeks after which gastroscopy with biopsies will be performed
If remission is lost they will return to the strict avoidance diet for at least 10 weeks after which they will return to the hospital for their second gastroscopy Upon remission after avoidance the children will remain eligible for another heat denatured food challenge when on diet for both
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