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临床试验/NCT01631591
NCT01631591已完成不适用

Prevalence of Food Allergies in a Cohort of Adult Patients With Eosinophilic Esophagitis

University of South Florida1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Prevalence of food allergies in a cohort of adult patients with EE.

研究概览

简要总结

Eosinophilic esophagitis is characterized by an eosinophilic infiltration of the esophagus. It presents clinically with a variety of symptoms including dysphagia, emesis, and food impaction. Although the underlying mechanism is different, gastroesophageal reflux can present with similar clinical findings but can be distinguished from eosinophilic esophagitis by the number of eosinophils present on esophageal biopsy. In children, food allergies play a role in exacerbating eosinophilic esophagitis, but the role of food allergies in adults is uncertain. In this study, we aim to determine the prevalence of food allergies in a cohort of adults with eosinophilic esophagitis.

详细描述

Study Population Male and female subjects, ages 18 years and older with findings of > 15 eosinophils per high powered field by endoscopic esophageal biopsy. Patients should also have symptoms consistent with eosinophilic esophagitis including dysphagia, heartburn, epigastric pain, recurrent vomiting, or food impaction. The comparative group will include male and female subjects, ages 18 years and older with a previous diagnosis of gastroesophageal reflux with findings of < 15 eosinophils per high power field by endoscopic esophageal biopsy.

Inclusion Criteria

  1. Male and female subjects 18 years and older
  2. Previous diagnosis of eosinophilic esophagitis with clinical symptoms including heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as well > 15 eosinophils per high powered field (400x magnification) by endoscopic esophageal biopsy in both the proximal and distal esophagus
  3. Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered field (400x magnification) by endoscopic biopsy

Exclusion Criteria

  1. Male and female subjects less than 18 years of age
  2. Pregnant female subjects
  3. Subjects who are receiving systemic steroids and are unable to stop prior to enrollment
  4. Subjects who are receiving systemic antihistamines and are unable to stop prior to enrollment
  5. Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study
  6. Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or psoriasis who would be unable to complete skin or patch testing
  7. Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visit Risks Skin testing with prick methodology has a risk of systemic reaction of less than 0.1% per 40 tests, however, no deaths have been reported with this method of testing. Systemic reactions are readily treated using Injectable epinephrine with oral antihistamines and oral corticosteroids (prednisone). Patch testing has no known associated risk for development of systemic reactions. Phlebotomy is associated with a minimal risk of bleeding, significant local discomfort, and infection from the needle puncture.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female subjects 18 years and older
  • Previous diagnosis of eosinophilic esophagitis with clinical symptoms including heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as well > 15 eosinophils per high powered field (400x magnification) by endoscopic esophageal biopsy in both the proximal and distal esophagus
  • Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered field (400x magnification) by endoscopic biopsy

排除标准

  • Male and female subjects less than 18 years of age
  • Pregnant female subjects
  • Subjects who are receiving systemic steroids and are unable to stop prior to enrollment
  • Subjects who are receiving systemic antihistamines and are unable to stop prior to enrollment
  • Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study
  • Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or psoriasis who would be unable to complete skin or patch testing
  • Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visit

结局指标

主要结局

Prevalence of food allergies in a cohort of adult patients with EE.

时间窗: Study to close on or around May 2014

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard F. Lockey, MD

Division Director, Prinicpal Investogator

University of South Florida

研究点 (1)

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