Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— RENESE  

Official title:

Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858426
• Other study ID #: RENESE
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: July 30, 2022

Study information

• Verified date: February 2019
• Source: Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
• Contact: Carolina Gutierrez-Junquera, MD, PHD
• Phone: +34911916437
• Email: carolina.gutijun[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 30, 2022
• Est. primary completion date: November 1, 2020
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete histological remission	Complete histological remission response defined as =5 eosinophils/hpf in all biopsies performed	12 weeks
Secondary	Partial histological remission	Partial histological remission response defined as 5-15 eosinophils /hpf in all biopsies	12 weeks
Secondary	Clinical remission	Clinical remission (specific questionnaire)	12 weeks