[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07027826":3,"trial-entities:NCT07027826":107,"trial-summary:NCT07027826":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":40,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":95,"overall_officials":99,"references":102,"see_also_links":103},"NCT07027826","10002313","The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States","Use of the Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States","RECRUITING","2027-08-31","2026-05-06","2026-08-28","2026-09-02","National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,"Background:\n\nEosinophilic 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.\n\nObjective:\n\nTo test if the EST can diagnose EoE in people who have trouble swallowing.\n\nEligibility:\n\nAdults aged 18 to 65 years with trouble swallowing. They must have been born in the African continent or their parents were born in Africa.\n\nDesign:\n\nParticipants 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.\n\nParticipants 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.\n\nAt 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.\n\nParticipants will have a final visit in person, online, or by phone. They will take a survey and talk about their test results.","Study Description:\n\nEligible 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\u002Ftape strip samples will be obtained for additional biomarker studies.\n\nParticipants 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.\n\nPrimary Objective:\n\n-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.\n\nSecondary Objective:\n\n-Determine the frequency of EoE among African individuals presenting with dysphagia in the U.S. and Mali.\n\nPrimary Endpoint(s):\n\n* 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.\n* 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.\n\nSecondary Endpoints:\n\n-Proportion of EoE cases diagnosed in each cohort.",[19,20],"Dysphagia","Eosinophilic Esophagitis",[20,19,22],"Esophageal string test","INTERVENTIONAL","DIAGNOSTIC",[26],"NA",{"count":28,"type":29},70,"ESTIMATED",[31],{"type":32,"name":22,"description":33,"armGroupLabels":34},"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.",[22],[36],{"measure":37,"description":38,"timeFrame":39},"Sensitivity and specificity of the esophageal string test to detect Eosinophilic Esophagitis.","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.","End of study",[41],{"measure":42,"description":43,"timeFrame":39},"Proportion of Eosinophilic Esophagitis cases diagnosed in each cohort.","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.","ALL","18 Years","65 Years",false,{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Able to provide informed consent.\n2. Aged 18 to 65 years.\n3. Born in the African continent or their parents were born in Africa,\n4. Exhibiting symptoms of dysphagia and\u002For prior history of food impaction.\n5. 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.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Recent steroid use (systemic or swallowed\u002Ftopical corticosteroid) within 4 weeks prior to endoscopy.\n2. Recent use of dupilumab (Dupixent) within the last 6 months.\n3. Recent use of other biologic medications (within either 6 months or 5 half-lives, whichever is longer). Examples of biologic medications include:\n\n3a. mepolizumab (Nucala)\n\n3b. reslizumab (Cinqair, Cinqaero)\n\n3c. benralizumab (Fasenra)\n\n3d. cendakimab\n\n3e. tezepelumab (Tezspire)\n\n3f. barzolvolimab\n\n4\\. Individuals suffering from a bleeding diathesis (e.g., hemophilia, severe thrombocytopenia).\n\n5\\. Current use of anticoagulant medications.\n\n6\\. Pregnancy.\n\n7\\. Treatment with another investigational drug or other investigational intervention within 6 months or 5 half-lives whichever is longer.\n\n8\\. Individuals with a known history of any of the following:\n\n8a. eosinophilic esophagitis\n\n8b. esophageal stricture unable to be passed with an upper endoscope\n\n8c. esophageal cancer\n\n8d. esophageal motility disorder (e.g., achalasia)\n\n8e. esophageal varices\n\n8f. esophageal or gastric surgery including fundoplication\n\n8g. neurologic cause of dysphagia (e.g., stroke, Parkinson s disease, etc.)\n\n8h. allergy to gelatin\n\n8i. inability to swallow pills\n\n9\\. Any condition that, in the investigator s opinion, places the individual at undue risk by participating in the study.\n\nCo-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.",[53,54],"ADULT","OLDER_ADULT",[56,75,88],{"facility":57,"status":8,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":72},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[63,68],{"name":64,"role":65,"phone":66,"email":67},"Perla Adames Castillo, B.S.N.","CONTACT","301-402-8495","perla.adamescastillo@nih.gov",{"name":69,"role":65,"phone":70,"email":71},"Gregory Constantine, M.D.","(301) 633-6453","gregory.constantine@nih.gov",{"lat":73,"lon":74},38.98067,-77.10026,{"facility":76,"status":77,"city":78,"country":79,"contacts":80,"geoPoint":85},"Gabriel Toure University Hospital Center","NOT_YET_RECRUITING","Bamako","Mali",[81],{"name":82,"role":65,"phone":83,"email":84},"Yaya Coulibaly","223-79-24-44-64","yicoulibaly@icermali.org",{"lat":86,"lon":87},12.60915,-7.97522,{"facility":89,"status":77,"city":78,"country":79,"contacts":90,"geoPoint":94},"Mali International Center for Excellence in Research",[91],{"name":92,"role":65,"phone":93,"email":84},"Yaya Coulibaly, M.D.","(223) 792-4446",{"lat":86,"lon":87},[96],{"name":97,"role":65,"phone":70,"email":98},"Gregory M Constantine, M.D.","constantinegm@nih.gov",[100],{"name":97,"affiliation":13,"role":101},"PRINCIPAL_INVESTIGATOR",[],[104],{"label":105,"url":106},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_002313-I.html",{"nct_id":4,"conditions":108,"biomarkers":109},[19,20],[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study planning to enroll 70 participants. Participants in the U.S. and Mali will have an Esophageal String Test (EST) before a planned endoscopy.","completed","Esophageal String Test for Eosinophilic Esophagitis in People with Dysphagia","This study is testing if a simpler, less invasive test called the Esophageal String Test (EST) can accurately diagnose Eosinophilic Esophagitis (EoE), a condition causing inflammation in the esophagus (the tube that moves food to your stomach). Currently, EoE is diagnosed using an endoscopy, which is a more involved procedure. Researchers want to see if the EST, which collects fluid from your upper digestive tract, can be a good alternative. You may be able to join if you are 18-65 years old, have trouble swallowing (dysphagia) or a history of food getting stuck, and were born in Africa or have parents born in Africa. The study will determine how well the EST identifies EoE compared to current methods.","The primary endpoint is measured at the end of the study, but specific follow-up duration is not detailed.",118,"You will be screened, provide blood, stool, urine, and skin swab samples, and complete questionnaires. An Esophageal String Test will be performed before your endoscopy.","Not stated in the trial record.",[22],"v2"]