Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

NCT01846962 | Completed Phase 4

• 1 other identifier: Pediatric-EoE
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic strategies for eosinophilic esophagitis (EoE) actually include: 1) allergen avoidance through dietary modifications, and 2) pharmacologic antiinflammatory therapy. Medical treatment is mainly based on topical administration of corticosteroids by swallowing fluticasone propionate or budesonide spray. Dietetic treatment with highest efficacy is elemental diet, consisting in exclusive feeding with amino-acid based formulas, often administered trough SNG. Alternative choices of acceptable efficacy are empirical six-foods elimination diet (cow's milk, egg, soy, wheat, peanuts, fish) and targeted elimination diet based on the results of allergy tests. Most of the paediatric patients with EE respond to elemental or targeted elimination diets, and therefore such authors recommend elimination diets to be considered the treatment of choice in children. However, elimination diets can often be complex to follow and may be associated with poor adherence owing to the low palatability of a highly restricted diet. In non-compliant patients, especially in adolescents and young adults, it may be more practical to proceed first with corticosteroid treatment. In the case of partial response to elimination diets or corticosteroids, a combination of both treatment mod. However, there has been limited testing of these regimens in randomized controlled trials, while most of available literature is based on case series. The aim of this study was to compare the efficacy of six-foods elimination diet, swallowed fluticasone, swallowed budesonide and oral viscous budesonide (OVB) in pediatric patients with active EoE. The investigators assessed the effects of randomly assigned treatment on clinical and endoscopic/histologic severity as primary and secondary outcomes, respectively. The investigators describe clinical, allergological, endoscopic and histological features, and pH study results, of our pediatric population.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic esophagitis (EoE); budesonide; fluticasione; six-foods elimination diet

Outcome Measures

Primary Outcomes (1)

• Efficacy Clinical Severity Score

  The primary outcome measure was the Clinical Severity Score assessed at baseline (time 0) and after 3 months of treatment (time 1). We scored each symptom basing on its frequency, intensity, and interference on life quality. One point was added in the presence of feeding difficulties leading to growth delay (weight/heigth ratio \<5° centile) or significant weight loss (\>10% of initial body weight). Two points were added the in case of gastrointestinal bleeding or severe strictures requiring urgent hospitalization.

  3 months

Secondary Outcomes (1)

• Efficacy Severity Score for Endoscopy and Histology

  3 months

Study Arms (4)

six-foods elimination diet

EXPERIMENTAL

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.

Behavioral: six-foods elimination diet

fluticasone

EXPERIMENTAL

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.

Drug: Fluticasone

Budesonide

EXPERIMENTAL

The administered dose of topical steroid was 400mcg/day or 800 mcg/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: Budesonide

Oral Viscous Budesonide (OVB)

EXPERIMENTAL

The administered dose of topical steroid was 1 or mg/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.

Drug: Oral Viscous Budesonide (OVB)

Interventions

Budesonide DRUG

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.

Budesonide

Fluticasone DRUG

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.

fluticasone

six-foods elimination diet BEHAVIORAL

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.

six-foods elimination diet

Oral Viscous Budesonide (OVB) DRUG

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.

Oral Viscous Budesonide (OVB)

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- suspected, or previously diagnosed, EoE in phase of clinical activity.
• Diagnostic criteria were:
• suggestive esophageal symptoms (GERD-like disease, dysphagia, food impaction);
• a negative 24 hours pH-impedenzometric study or, whether positive, the refractoriness to a high dose proton pump inhibitor (PPI) therapy for at least 8 weeks;
• the histological demonstration of \>15/20 eosinophils/HPF on at least 1 esophageal biopsy. Patients who received any dietetic or antiinflammatory treatment in the last 6 months were dropped out, and no allergy therapy was allowed during the study

You may not qualify if:

• diagnosis of concomitant inflammatory, rheumatic or infectious disease,
• and the assumption of any dietetic or therapy since the clinical onset.

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead

Study Sites (1)

Departments of Pediatrics, Sapienza - University of Rome

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Budesonide; Fluticasone

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstadienes; Androstenes; Androstanes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 6, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

IT (1)