Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis
Recruitment status was: Recruiting
| Tracking Information | |||
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| First Received Date ICMJE | April 30, 2013 | ||
| Last Updated Date | May 3, 2013 | ||
| Start Date ICMJE | November 2012 | ||
| Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE |
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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| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis | ||
| Official Title ICMJE | 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 investigators describe clinical, allergological, endoscopic and histological features, and pH study results, of our pediatric population. |
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| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Eosinophilic Esophagitis | ||
| Intervention ICMJE |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Unknown status | ||
| Estimated Enrollment ICMJE | 60 | ||
| Estimated Completion Date | June 2013 | ||
| Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - suspected, or previously diagnosed, EoE in phase of clinical activity. Diagnostic criteria were:
Exclusion Criteria:
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| Ages | 6 Months to 18 Years (Child, Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Italy | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01846962 | ||
| Other Study ID Numbers ICMJE | Pediatric-EoE | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Giovanni Di Nardo, Azienda Policlinico Umberto I | ||
| Study Sponsor ICMJE | Azienda Policlinico Umberto I | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Azienda Policlinico Umberto I | ||
| Verification Date | November 2012 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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