Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

PHASE4CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

June 30, 2013

Conditions
Eosinophilic Esophagitis
Interventions
DRUG

Budesonide

The administered dose of topical steroid was 400mcg or 800mcg/day (\<150 cm or \>150 cm). Patients were trained to swallow puffs and to non eat or drink fo 30 minutes after ingestion. Patients noncompliant with therapy, monthly assessed by Pediatric Allergologists, were withdrawn from the study.

DRUG

Fluticasone

The administered dose of topical steroid was 440mcg or 880mcg/day (\<150 cm or \>150 cm). Patients were trained to swallow puffs and to non eat or drink fo 30 minutes after ingestion. Patients noncompliant with therapy, monthly assessed by Pediatric Allergologists, were withdrawn from the study.

BEHAVIORAL

six-foods elimination diet

six-foods elimination diet. The standard panel of foods tested included the 6 most common allergenic foods in childhood (cow's milk, egg, soy, wheat, peanuts, fish), plus foods that were suspiciously implicated in triggering an allergic reaction referred by patients or their parents. Both perennial (dust mite, Parietaria, Alternaria, cat and dog dander) and seasonal (grass pollen including Graminaceae, Olea europea, Platanus) aeroallergens have been tested.

DRUG

Oral Viscous Budesonide (OVB)

The administered dose of topical steroid was 1mg/day or 2mg/day (\<150 cm or \>150 cm). Patients were trained to prepare a homemade suspension of OVB prepared by mixing inhaled budesonide with viscous solutions of sodium alginate and to non eat or drink fo 30 minutes after ingestion. Patients noncompliant with therapy, monthly assessed by Pediatric Allergologists, were withdrawn from the study.

Trial Locations (1)

00161

Departments of Pediatrics, Sapienza - University of Rome, Rome

All Listed Sponsors
lead

Azienda Policlinico Umberto I

OTHER

NCT01846962 - Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis | Biotech Hunter | Biotech Hunter