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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07027826
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gregory M Constantine, M.D.
Principal Investigator Affiliation National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Not yet recruiting
Countries Mali, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dysphagia, Eosinophilic Esophagitis
Study Website: View Trial Website
Additional Details

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-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.

Arms & Interventions

Arms

Experimental: Esophageal string test

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

Interventions

Device: - 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.

Contact a Trial Team

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Bethesda, Maryland

Status

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

Perla Adames Castillo, B.S.N.

[email protected]

301-402-8495

International Sites

Gabriel Toure University Hospital Center, Bamako, Mali

Status

Address

Gabriel Toure University Hospital Center

Bamako, ,

Site Contact

Yaya Coulibaly

[email protected]

223-79-24-44-64

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