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

NCT01631591 | Completed DMC

• 1 other identifier: eosinophilic esophagitis
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eosinophilic Esophagitis; Food Allergies

Outcome Measures

Primary Outcomes (1)

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

  Study to close on or around May 2014

Study Arms (2)

eosinophilic esophagitis

PATIENTS WITH A CURRENT DIAGNOSIS OF eosinophilic esophagitis.

GERD

PATIENTS WITH A DIAGNOSIS WITH GERD.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director, Prinicpal Investogator

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: May 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

US (1)