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Status unknownNCT03858426RENESEUpdated Feb 28, 2019

Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

An observational study in Eosinophilic Esophagitis, sponsored by Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica. Status unknown at 1 site in Spain. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2019-02-28.

Sponsored by Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
1 Month to 18 Years
Sex
All
01

Study 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
02

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's planned enrollment of 500 is above the median of 100 across 91 observational studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

This is the only study on the registry with Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
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

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. Complete histological remission

    Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed

    Time frame: 12 weeks

Secondary outcomes

  1. Partial histological remission

    Partial histological remission response defined as 5-15 eosinophils /hpf in all biopsies

    Time frame: 12 weeks

  2. Clinical remission

    Clinical remission (specific questionnaire)

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario Puerta de Hierro Majadahonda
    Madrid, 28222, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03858426
Lead sponsor
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Responsible party
Carolina Gutierrez Junquera (Principal Investigator, Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica) — Principal investigator
First posted
Feb 28, 2019
Start date
Jan 1, 2019
Primary completion
Nov 1, 2020 (estimated)
Completion
Jul 30, 2022 (estimated)
Last update
Feb 28, 2019

Study contacts

Carolina Gutierrez-Junquera, MD, PHD
Contact
carolina.gutijun@salud.madrid.org
+34911916437
Belén Ruiz-Antorán, MD, PHD
Contact
mariabelen.ruiz@salud.madrid.org
+34911917479

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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