Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06190080

Outcome of Children With Eosinophilic Esophagitis

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Esophagitis, Eosinophilic Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

Digestive endoscopy

Other

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.

Primary outcomes

  1. Determine the rate of complete remission

    Time frame: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.

    Complete remission will be defined according to the following criteria:

    • Abolition of clinical symptoms as assessed by the Pediatric Eosinophilic Esophagitis Symptom Score
    • Endoscopic score: EoE Endoscopic Reference Score (EREFS) ≤ 2 in the lower, middle and upper thirds of the esophagus.
    • Eosinophilic infiltrate < 5/HPF in standard HES (Haemato-Eosin-Safran) stain on biopsies from lower, middle and upper thirds of esophagus
    • No therapeutic change at follow-up visit to assess remission

Secondary outcomes

  1. Description at inclusion of a cohort of pediatric patients with OE

    Time frame: throught a 24 months follow-up

    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)

  2. evolution of quality of life

    Time frame: at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Mouchet

CONTACT

[email protected]

Mathilde Butori Pepino, MD

CONTACT

[email protected]

04.92.03.10.12

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

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

Acronym: Obs-OE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 5, 2024
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.