NCT06190080

Outcome of Children With Eosinophilic Esophagitis

Outcomes of Children With Eosinophilic Esophagitis: a Prospective Monocentric Observational Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Fondation Lenval · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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

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 patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 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.

Conditions

• Esophagitis, Eosinophilic

Interventions

Type	Name	Description
OTHER	Digestive endoscopy	Digestive 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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2028-03-01
• Completion: 2028-12-01
• First posted: 2024-01-05
• Last updated: 2024-01-16

Locations

1 site across 1 country: France