Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis (RENESE)

1. Registry of demographic, clinical, endoscopic and histological data at baseline.

2. Registry of patients treated with PPI:

   • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   • Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment

3. Registry of patients treated with two foods elimination diet:

   • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   • Identification of food trigger: milk, gluten or milk and gluten
   • Clinical, endoscopic and histological response at one year elimination of food trigger
   • Registry of adverse events

4. Registry of patients treated with swallowed steroids (budesonide or fluticasone):

   • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   • Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
   • Registry of adverse events

Study Overview

• Status: Unknown
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Carolina Gutierrez-Junquera, MD, PHD; Phone Number: +34911916437; Email: carolina.gutijun@salud.madrid.org
• Study Contact Backup: Name: Belén Ruiz-Antorán, MD, PHD; Phone Number: +34911917479; Email: mariabelen.ruiz@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
    • Contact: Carolina Gutierrez Junquera, PhD; Phone Number: 911916437; Email: carolina.gutijun@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to the recent European guidelines

Description

Inclusion Criteria:

• Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
• And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .

Exclusion Criteria:

• Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
• Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children with eosinophilic esophagitis; Inclusion criteria: Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA); And they need to start treatment with one of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids Exclusion criteria: Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis); Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete histological remission	Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial histological remission	Partial histological remission response defined as 5-15 eosinophils /hpf in all biopsies	12 weeks
Clinical remission	Clinical remission (specific questionnaire)	12 weeks

Collaborators and Investigators

• Sponsor: Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: RENESE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No