Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07027826

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-14

70

Participants Needed

3

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 the African continent or their parents were born in Africa. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent.
  • Aged 18 to 65 years.
  • Born in the African continent or their parents were born in Africa.
  • Exhibiting symptoms of dysphagia and/or prior history of food impaction.
  • Undergoing clinically indicated endoscopy at the NIH Clinical Center (U.S.), Centre Hospitalier Universitaire Gabriel Tour (Mali), or other local clinics (Mali) and willing to provide research samples and data.
Not Eligible

You will not qualify if you...

  • Recent steroid use (systemic or swallowed/topical corticosteroid) within 4 weeks prior to endoscopy.
  • Recent use of dupilumab (Dupixent) within the last 6 months.
  • Recent use of other biologic medications within 6 months or 5 half-lives, whichever is longer, including mepolizumab, reslizumab, benralizumab, cendakimab, tezepelumab, barzolvolimab.
  • Individuals with bleeding disorders such as hemophilia or severe thrombocytopenia.
  • Current use of anticoagulant medications.
  • Pregnancy.
  • Treatment with another investigational drug or intervention within 6 months or 5 half-lives.
  • Known history of eosinophilic esophagitis.
  • Esophageal stricture that cannot be passed with an upper endoscope.
  • Esophageal cancer.
  • Esophageal motility disorders (e.g., achalasia).
  • Esophageal varices.
  • Prior esophageal or gastric surgery including fundoplication.
  • Neurologic causes of dysphagia such as stroke or Parkinson's disease.
  • Allergy to gelatin.
  • Inability to swallow pills.
  • Any condition that places the individual at undue risk as judged by the investigator.

AI-Screening

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Trial Site Locations

Total: 3 locations

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

2

Gabriel Toure University Hospital Center

Bamako, Mali

Not Yet Recruiting

3

Mali International Center for Excellence in Research

Bamako, Mali

Not Yet Recruiting

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Research Team

G

Gregory M Constantine, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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