Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT07027826
RecruitingNCT07027826ClinicalTrials.gov record

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

Dysphagia · Eosinophilic Esophagitis

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 65 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
70 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

Study Description:

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 individuals presenting with dysphagia in the U.S. and Mali.

Secondary Objective:

-Determine the frequency of EoE among African 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

  • 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 or their parents were born in Africa,
4. Exhibiting symptoms of dysphagia and/or prior history of food impaction.
5. 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.

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)

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
Esophageal string test

The esophageal string test is a minimally invasive procedure used to collect esophageal secretions for diagnostic analysis.

Device: Esophageal string test

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

Time frame: End of study

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.

Secondary measures

Proportion of Eosinophilic Esophagitis cases diagnosed in each cohort.

Time frame: End of study

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

National Institutes of Health Clinical CenterBethesda, Maryland, United StatesRecruiting
Gabriel Toure University Hospital CenterBamako, MaliNot yet recruiting
Mali International Center for Excellence in ResearchBamako, MaliNot yet recruiting

Study team and timeline

Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study start
Nov 15, 2026 Estimated
Primary completion
Aug 31, 2027 Estimated
Study completion
Aug 31, 2027 Estimated
First posted
Jun 19, 2025 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Gregory M Constantine, M.D.CONTACTconstantinegm@nih.gov(301) 633-6453
Official study title

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026