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An Adult and Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study


Title Development, Validation, and Evaluation of an Adult and Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study
Therapeutic Area Eosinophilic Esophagitis
Principal Investigator John Leung MD
Min Age 18 Years
Max Age 75 Years
Gender All
Contact Tess Brown
617 636-4941
More Information https://clinicaltrials.gov/ct2/show/NCT00939263

Overview

Eosinophilic Esophagitis (EoE) is a swallowing disorder which is caused by an allergy-like inflammation of the esophagus. It is diagnosed by esophageal biopsies and can be treated with anti-inflammatory medicines. There are cases of EoE in children and adults and the symptoms primarily present with difficulty swallowing or the feeling of food being stuck in the esophagus. Currently there is no exact way to define the activity of Eosinophilic Esophagitis. An activity index for measuring the disease severity has not been developed so there is difficulty in measuring the treatment responses in clinical studies. The creation of an Activity Index (or a score) for EoE will allow the objective measurement of patient symptoms.

The aim of the current multi-center study is to develop, validate and evaluate an EoE activity index for pediatric and adult patients. Our site at Tufts will soley be involved in the adult population of patients with EoE. The study is purely observational and involves undergoing a structured interview from the research coordinator involved in the study in addition to the standard medical care (including medicines, endoscopic evaluations and biopsies, for example) by one of the investigators of the study. There is also a questionnaire that the patients will have to fill out. There are several items in the questionnaire measuring the symptoms (eg frequency of dysphagia, dysphagia in relation to distinct food consistencies). There is also a component where the biologic activity (number of eosinophils in esophageal biopsy or presence of signs of acute inflammation in esophagoscopy) will be incorporated. The biologic activity component will be completed by the principal or co-investigators who are caring for the patients.

Study Details

Inclusion Criteria

  • Patients who had an upper endoscopy for initial diagnosis, for confirming a suspected diagnosis, or for monitoring a previously diagnosed Eosinophilic Esophagitis (EoE).
  • Patients who fulfill the established clinical and histological criteria to confirm the diagnosis of EoE.
  • EoE patients with concomitant gastroesophageal reflux disease (GERD).

Exclusion Criteria

  • Concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, IBD, esophageal infection with 12 viruses and candida)
  • Systemic disease (e.g. AIDS).

Study Requirements

2 blood samples when subject comes for EDG, aproximately 20 cc of blood.