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Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03858426
Acronym
RENESE
Enrollment
500
Registered
2019-02-28
Start date
2019-01-01
Completion date
2022-07-30
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

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

Brief 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

Interventions

OTHERno intervention

no intervention

Sponsors

Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
Complete histological remission12 weeksComplete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed

Secondary

MeasureTime frameDescription
Partial histological remission12 weeksPartial histological remission response defined as 5-15 eosinophils /hpf in all biopsies
Clinical remission12 weeksClinical remission (specific questionnaire)

Countries

Spain

Contacts

Primary ContactCarolina Gutierrez-Junquera, MD, PHD
carolina.gutijun@salud.madrid.org+34911916437
Backup ContactBelén Ruiz-Antorán, MD, PHD
mariabelen.ruiz@salud.madrid.org+34911917479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026