Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis - Full Text View

Purpose

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 versus swallowed fluticasone versus budesonide 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. In addiction, we assessed the efficacy of combined therapy (diet plus topical steroids) administered to non responding patients. The investigators describe clinical, allergological, endoscopic and histological features, and pH study results, of our pediatric population.

Condition	Intervention	Phase
Eosinophilic Esophagitis	Drug: Budesonide Drug: Fluticasone Behavioral: six-foods elimination diet	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	COMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS)

Resource links provided by NLM:

Drug Information available for: Budesonide

Genetic and Rare Diseases Information Center resources: Eosinophilic Enteropathy

U.S. FDA Resources

Further study details as provided by Giovanni Di Nardo, Azienda Policlinico Umberto I:

Primary Outcome Measures:

Efficacy Clinical Severity Score [ Time Frame: 3 months ]
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.

Secondary Outcome Measures:

Efficacy Severity Score for Endoscopy and Histology [ Time Frame: 3 months ]
Secondary outcome measurements were the Severity Score for Endoscopy and Histology assessed at time 0 and 1


Estimated Enrollment:	60
Study Start Date:	November 2012
Estimated Study Completion Date:	June 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	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.
Experimental: fluticasone The administered dose of topical steroid was 0.5 mg/2 mL. 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 0.5 mg/2 mL. 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.
Experimental: Budesonide The administered dose of topical steroid was 0.5 mg/2 mL. 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 The administered dose of topical steroid was 0.5 mg/2 mL. 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.

Detailed Description:

Eosinophilic esophagitis (EoE) is characterized by significant eosinophilic infiltration of esophageal mucosa, leading to tissue damage and consequently to esophageal symptoms. The clinical presentation in childhood often mimics gastro-esophageal reflux disease (GERD), sometimes in association to feeding difficulties and failure to thrive. Later in life, the most common symptoms are dysphagia and food impaction, due to esophageal dysmotility. The progression of a non-recognized, untreated disease, is thought to lead to chronic esophageal inflammation with fibrosis and stenosis. Diagnosis requires multiple esophageal biopsies (at least 4 in both proximal and distal esophagus, regardless of gross appearance of mucosa) to demonstrate a mucosal infiltrate of at least 15 eosinophils for high power field (HPF) in patients with a normal pH study or refractory to acid-suppression therapy. Although the endoscopic examination may be unremarkable, endoscopic features of EoE have been well characterized and include: linear furrowing, concentric rings (thachealization), white spots (eosinophilic abscesses), Schatzki ring, strictures, and linear superficial mucosal tears occurring after introduction of the endoscope.

Eligibility


Ages Eligible for Study:	6 Months to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846962

Locations


Italy
Departments of Pediatrics, Sapienza - University of Rome	Recruiting
Rome, Italy, 00161
Contact: Giovanni Di Nardo, MD +390649979326 giovanni.dinardo@uniroma1.it
Principal Investigator: Giovanni Di Nardo, MD

Sponsors and Collaborators

Azienda Policlinico Umberto I

More Information


Responsible Party:	Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:	NCT01846962 History of Changes
Other Study ID Numbers:	Pediatric-EoE
Study First Received:	April 30, 2013
Last Updated:	May 3, 2013

Keywords provided by Giovanni Di Nardo, Azienda Policlinico Umberto I:


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

Additional relevant MeSH terms:


Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide	Fluticasone Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dermatologic Agents Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 11, 2017