The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Use of the Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
2 other identifiers
interventional
70
2 countries
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedStudy Start
First participant enrolled
May 11, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
Study Completion
Last participant's last visit for all outcomes
August 31, 2027
May 6, 2026
April 10, 2026
1.3 years
June 18, 2025
May 5, 2026
Conditions
Keywords
Outcome Measures
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.
End of study
Secondary Outcomes (1)
Proportion of Eosinophilic Esophagitis cases diagnosed in each cohort.
End of study
Study Arms (1)
Esophageal string test
EXPERIMENTALThe esophageal string test is a minimally invasive procedure used to collect esophageal secretions for diagnostic analysis.
Interventions
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.
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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(SqrRoot)(Copyright) (Mali), or other local clinics (Mali) and willing to provide research samples and data.
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 either 6 months or 5 half-lives, whichever is longer). Examples of biologic medications include:
- a. mepolizumab (Nucala)
- b. reslizumab (Cinqair, Cinqaero)
- c. benralizumab (Fasenra)
- d. cendakimab
- e. tezepelumab (Tezspire)
- f. barzolvolimab
- \. Individuals suffering from a bleeding diathesis (e.g., hemophilia, severe thrombocytopenia).
- \. Current use of anticoagulant medications.
- \. Pregnancy.
- \. Treatment with another investigational drug or other investigational intervention within 6 months or 5 half-lives whichever is longer.
- \. Individuals with a known history of any of the following:
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Gabriel Toure University Hospital Center
Bamako, Mali
Mali International Center for Excellence in Research
Bamako, Mali
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory M Constantine, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2025
First Posted
June 19, 2025
Study Start (Estimated)
May 11, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
May 6, 2026
Record last verified: 2026-04-10
Data Sharing
- IPD Sharing
- Will not share