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Recruiting NCT07027826

The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States

Trial Parameters

Condition Dysphagia
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2026-04-05
Completion 2027-08-31
Interventions
Esophageal string test

Brief Summary

Background: Eosinophilic esophagitis (EoE) is a disease that causes inflammation in the esophagus. The esophagus is the tube that moves food from the mouth to the stomach. Diagnosing EoE currently requires a specialized tool called an endoscope. The esophageal string test (EST) is another test; the EST collects fluid from the upper digestive tract. An EST is simpler and cheaper than an endoscopy. Researchers want to know if an EST can diagnose EoE. Objective: To test if the EST can diagnose EoE in people who have trouble swallowing. Eligibility: Adults aged 18 to 65 years with trouble swallowing. They must have been born in Africa and be of African descent. Design: Participants will be screened. They will give blood, stool, urine, and skin swab samples. They will complete surveys about their medical history, diet, symptoms, and home environment. They will bring a sample of their drinking water for testing. Participants will have an EST. They will swallow a pill capsule that contains a nylon string. One end of the string will be taped to their cheek. The string will unravel down the esophagus and into the stomach. It will be pulled out after 1 hour. Fluids that soaked into the string will be tested. At a different visit, participants will have an endoscopic exam. An endoscope is a flexible tube that is inserted down the mouth; it can be used to take tissue samples from the esophagus, stomach, and small intestine. Participants will have a final visit in person, online, or by phone. They will take a survey and talk about their test results.

Eligibility Criteria

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Able to provide informed consent. 2. Aged 18 to 65 years. 3. Born in the African continent and of African ancestry. 4. Exhibiting symptoms of dysphagia and/or prior history of food impaction. 5. Undergoing clinically indicated endoscopy at the NIH Clinical Center or Centre Hospitalier Universitaire Gabriel Toure and willing to provide research samples and data. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Recent steroid use (systemic or swallowed/topical corticosteroid) within 4 weeks prior to endoscopy. 2. Recent use of dupilumab (Dupixent) within the last 6 months. 3. Recent use of other biologic medications (within either 6 months or 5 half-lives, whichever is longer). Examples of biologic medications include: 3a. mepolizumab (Nucala) 3b. reslizumab (Cinqair, Cinqaero)

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