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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Recent steroid use (systemic or swallowed/topical corticosteroid) within 4 weeks prior to endoscopy.

Recent use of dupilumab (Dupixent) within the last 6 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Esophageal string test

    Device

    The esophageal string test consists of a gelatin or cellulose capsule containing a nylon string. The capsule dissolves allowing the nylon string to absorb esophageal secretions which can be analyzed for various inflammatory mediators.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Esophageal string testExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity and specificity of the esophageal string test to detect Eosinophilic Esophagitis.

Assess the accuracy of the 1-hour EST as a diagnostic screening tool for EoE in populations with limited access to subspecialty care. Sensitivity and specificity provide a measure of accuracy when compared to the diagnostic gold standard.

Time frame
End of study

Secondary outcomes

1

Proportion of Eosinophilic Esophagitis cases diagnosed in each cohort.

Determine the frequency of EoE among African individuals presenting with dysphagia in the U.S. and Mali. Allows for the comparison of diagnostic rates across different groups, providing insights into the prevalence.

Time frame
End of study

Other outcomes

Sponsors and contacts

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