Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Budesonide; Fluticasone; six-foods elimination diet; Oral Viscous Budesonide (OVB)
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): 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.; 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.; 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.; 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.
Intervention MeSH terms: Fluticasone; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eosinophilic esophagitis (EoE); budesonide; fluticasione; six-foods elimination diet