Protocol Details
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 is currently recruiting participants.
Summary
Number |
002313-I |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Adults who are or may become unable to consent;
American Indian or Alaskan Native;
Asian;
Children;
Fetuses;
Hispanic or Latino;
Native Hawaiian/Pacific Islander;
Neonates;
Pregnant Women;
White |
Keywords |
Eosinophilic Esophagitis;
Dysphagia;
Esophageal string test |
Recruitment Keyword(s) |
None |
Condition(s) |
Dysphagia;
Eosinophilic Esophagitis |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Device: Esophageal string test
|
Supporting Site |
National Institute of Allergy and Infectious Diseases |
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 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.
Eligibility
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 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:
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT07027826