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
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 65 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 70 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
- 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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Sensitivity and specificity of the esophageal string test to detect Eosinophilic Esophagitis.
Plazo: 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.
Medidas secundarias
Proportion of Eosinophilic Esophagitis cases diagnosed in each cohort.
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (3)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
3 centros
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesReclutando
Gabriel Toure University Hospital CenterBamako, MaliAún no recluta
Mali International Center for Excellence in ResearchBamako, MaliAún no recluta
Equipo y fechas
- Patrocinador principal
- National Institute of Allergy and Infectious Diseases (NIAID)
- Inicio del estudio
- 15 nov 2026 Estimado
- Finalización primaria
- 31 ago 2027 Estimado
- Finalización del estudio
- 31 ago 2027 Estimado
- Primera publicación
- 19 jun 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Use of the Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026