Clinical Trial: Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: COMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS)

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 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 investig

Detailed Summary: 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.
Sponsor: Azienda Policlinico Umberto I

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Azienda Policlinico Umberto I

Dates:
Date Received: April 30, 2013
Date Started: November 2012
Date Completion: June 2013
Last Updated: May 3, 2013
Last Verified: November 2012