The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
NCT ID: NCT07027826
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
70 participants
INTERVENTIONAL
2025-11-17
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Eligible participants will be enrolled to assess the performance and accuracy of the 1-hour esophageal string test (EST) as a diagnostic screening tool for eosinophilic esophagitis (EoE). Consenting participants in the U.S. (n=30) and Mali (n=30) undergoing clinically indicated esophagogastroduodenoscopy (EGD) will have an EST performed prior to the procedure. Clinical data, including medical history and laboratory test results, will be captured on a case report form. Symptoms will also be assessed using validated patient reporting outcome measures: the Brief Esophageal Dysphagia Questionnaire (BEDQ) and Patient-Reported Outcomes Measurement Information System (PROMIS-GI and -57). Dietary, sociodemographic, and environmental histories will be obtained by validated questionnaires. Blood, urine, stool, and skin swab/tape strip samples will be obtained for additional biomarker studies.
Participants will be screened for intestinal helminth infections by stool polymerase chain reaction (PCR). Tissue samples obtained during EGD will be assessed for Helicobacter pylori by histopathology. Esophageal biopsy samples and remaining EST eluents will be allocated for investigational studies. Air and water samples will be collected from areas within the participants community and analyzed to determine potential correlation with elevated levels of environmental pollutants. The hypothesis of this study is that the 1-hour EST will provide a preliminary estimate of EoE prevalence among Africans and African immigrants presenting with dysphagia.
Primary Objective:
-Assess the accuracy of the 1-hour EST as a diagnostic screening tool for EoE among African-born individuals presenting with dysphagia in the U.S. and Mali.
Secondary Objective:
-Determine the frequency of EoE among African-born individuals presenting with dysphagia in the U.S. and Mali.
Primary Endpoint(s):
* Sensitivity, as estimated by the proportion of positive EST-obtained EoE-Score(TM) results out of those diagnosed with EoE by the gold standard of esophageal biopsy.
* Specificity, as estimated by the proportion of negative EST-obtained EoE-Score(TM) results out of those diagnosed with EoE by the gold standard of esophageal biopsy.
Secondary Endpoints:
-Proportion of EoE cases diagnosed in each cohort.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Esophageal string test
The esophageal string test is a minimally invasive procedure used to collect esophageal secretions for diagnostic analysis.
Esophageal string test
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Esophageal string test
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
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)
3c. benralizumab (Fasenra)
3d. cendakimab
3e. tezepelumab (Tezspire)
3f. barzolvolimab
4\. Individuals suffering from a bleeding diathesis (e.g., hemophilia, severe thrombocytopenia).
5\. Current use of anticoagulant medications.
6\. Pregnancy.
7\. Treatment with another investigational drug or other investigational intervention within 6 months or 5 half-lives whichever is longer.
8\. Individuals with a known history of any of the following:
8a. eosinophilic esophagitis
8b. esophageal stricture unable to be passed with an upper endoscope
8c. esophageal cancer
8d. esophageal motility disorder (e.g., achalasia)
8e. esophageal varices
8f. esophageal or gastric surgery including fundoplication
8g. neurologic cause of dysphagia (e.g., stroke, Parkinson s disease, etc.)
8h. allergy to gelatin
8i. inability to swallow pills
9\. Any condition that, in the investigator s opinion, places the individual at undue risk by participating in the study.
Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the principal investigator in consultation with the medical monitor. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gregory M Constantine, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Gabriel Toure University Hospital Center
Bamako, , Mali
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Perla Adames Castillo, B.S.N.
Role: primary
Gregory Constantine, M.D.
Role: backup
Yaya Coulibaly
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
002313-I
Identifier Type: -
Identifier Source: secondary_id
10002313
Identifier Type: -
Identifier Source: org_study_id