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Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT01846962
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Salvatore Oliva, Azienda Policlinico Umberto I

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.


Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Budesonide Drug: Fluticasone Behavioral: six-foods elimination diet Drug: Oral Viscous Budesonide (OVB) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS)
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
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 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
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.

Experimental: Budesonide
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
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.

Experimental: Oral Viscous Budesonide (OVB)
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)
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.




Primary Outcome Measures :
  1. 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 :
  1. 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



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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:

  1. suggestive esophageal symptoms (GERD-like disease, dysphagia, food impaction);
  2. 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;
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846962


Locations
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Italy
Departments of Pediatrics, Sapienza - University of Rome
Rome, Italy, 00161
Sponsors and Collaborators
Azienda Policlinico Umberto I

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Responsible Party: Salvatore Oliva, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01846962     History of Changes
Other Study ID Numbers: Pediatric-EoE
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Keywords provided by Salvatore Oliva, Azienda Policlinico Umberto I:
Eosinophilic esophagitis (EoE)
budesonide
fluticasione
six-foods elimination diet
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists