This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Giovanni Di Nardo, Azienda Policlinico Umberto I.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT01846962
First received: April 30, 2013
Last updated: May 3, 2013
Last verified: November 2012
April 30, 2013
May 3, 2013
November 2012
April 2013   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis
COMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS)

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Eosinophilic Esophagitis
  • 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.
  • 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.
  • 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: 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.
    Intervention: Behavioral: six-foods elimination diet
  • 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.
    Intervention: Drug: Fluticasone
  • 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.
    Intervention: Drug: Budesonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
June 2013
April 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Months to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01846962
Pediatric-EoE
No
Not Provided
Not Provided
Giovanni Di Nardo, Azienda Policlinico Umberto I
Azienda Policlinico Umberto I
Not Provided
Not Provided
Azienda Policlinico Umberto I
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP