Esophageal String Test for Eosinophilic Esophagitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a simpler test, the esophageal string test (EST), can diagnose eosinophilic esophagitis (EoE), an inflammatory condition that makes swallowing difficult. The EST involves swallowing a pill attached to a string that collects fluid from the esophagus for testing. The trial seeks participants of African descent who have difficulty swallowing. Participants will undergo both the EST and a traditional endoscopy to compare results. As an unphased trial, this study offers a unique opportunity to contribute to research that may simplify EoE diagnosis for future patients.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. You must not have used steroids in the last 4 weeks or certain biologic medications in the last 6 months. If you are currently using anticoagulant medications, you cannot participate.
What prior data suggests that the esophageal string test is safe for diagnosing EoE?
Studies have shown that the Esophageal String Test (EST) is a safe and easy method for diagnosing eosinophilic esophagitis (EoE). Research indicates that the EST can accurately differentiate between active and inactive EoE in both children and adults. This test is minimally invasive, making it simpler and less risky than other procedures. Participants in earlier studies did not report any major side effects, suggesting the test is generally safe. The EST involves swallowing a capsule attached to a string that collects fluid from the esophagus, which is then checked for signs of inflammation. Previous research has used this method without serious side effects, making it a promising tool for diagnosing EoE.12345
Why are researchers excited about this trial?
The Esophageal String Test is unique because it offers a minimally invasive way to collect esophageal secretions, making it easier and more comfortable for patients compared to traditional endoscopy and biopsy methods. Researchers are excited about this technique because it provides a simpler, less intrusive way to monitor Eosinophilic Esophagitis, potentially leading to more frequent and accurate assessments of the condition. This method could improve patient experience and compliance, while still delivering valuable diagnostic information.
What evidence suggests that the esophageal string test is effective for diagnosing eosinophilic esophagitis?
Research shows that the esophageal string test (EST), which participants in this trial will undergo, effectively diagnoses eosinophilic esophagitis (EoE). One study found that the EST had good accuracy, with a performance score of 0.83 out of 1. It correctly identified EoE in 80% of cases and accurately ruled it out in 75% of cases. This indicates the test's reliability in many instances. Additionally, many patients and parents preferred the EST over traditional endoscopy because it is simpler and less invasive. Overall, the EST appears to be a promising tool for monitoring and diagnosing EoE.12678
Who Is on the Research Team?
Gregory M Constantine, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 65 who have difficulty swallowing, are born in Africa, and of African descent. They will undergo screenings including blood, stool, urine tests, surveys about their health and environment, and provide a water sample.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Esophageal String Test
Participants undergo the esophageal string test to collect esophageal secretions for diagnostic analysis
Endoscopic Exam
Participants have an endoscopic exam to take tissue samples from the esophagus, stomach, and small intestine
Follow-up
Participants have a final visit to discuss test results and complete a survey
What Are the Treatments Tested in This Trial?
Interventions
- Esophageal String Test
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor