Esophageal string test to screen for eosinophilic esophagitis in adults of African descent with swallowing problems

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

This study will test whether a 1-hour esophageal string test can detect eosinophilic esophagitis in adults born in Africa (or with African parents) who have trouble swallowing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: dupilumab, mepolizumab, reslizumab, benralizumab, cendakimab, tezepelumab, barzolvolimab
• Locations: 3 sites (Bethesda, Maryland and 2 other locations)
• Trial ID: NCT07027826 on ClinicalTrials.gov

What this trial studies

The study enrolls adults aged 18–65 who were born in Africa or have parents born in Africa and who have symptoms of dysphagia and are scheduled for clinically indicated upper endoscopy in Mali or the United States. Each participant will undergo a 1-hour esophageal string test (EST) immediately prior to esophagogastroduodenoscopy, with biopsy results serving as the reference standard. Investigators will collect blood, urine, stool, skin swabs, environmental air and water samples, and standardized symptom and exposure questionnaires to explore biomarkers and potential environmental contributors. The main aim is to compare EST findings with biopsy results to estimate the EST’s accuracy for identifying eosinophilic esophagitis in this population.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with dysphagia or prior food impaction who were born in Africa or have parents born in Africa and who are willing to undergo the EST and a clinically indicated endoscopy.

Not a fit: People outside the 18–65 age range, without African birth or parentage, without swallowing symptoms, or who recently used systemic or topical steroids or certain biologic drugs are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the EST could offer a faster, cheaper, and less invasive way to screen for eosinophilic esophagitis and reduce reliance on diagnostic endoscopy.

How similar studies have performed: Previous studies have shown the EST can detect eosinophilic esophagitis in other populations, but its performance among people of African descent and in community settings remains less well established.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland and 2 other locations

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
• Gabriel Toure University Hospital Center — Bamako, Mali (Not_yet_recruiting)
• Mali International Center for Excellence in Research — Bamako, Mali (Not_yet_recruiting)

Study contacts

• Principal investigator: Gregory M Constantine, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Gregory M Constantine, M.D.

Conditions Dysphagia; Eosinophilic Esophagitis; Esophageal string test