70 Participants Needed

Esophageal String Test for Eosinophilic Esophagitis

Recruiting at 1 trial location
GM
Overseen ByGregory M Constantine, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

GM

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

Able to provide informed consent
I am willing to give samples and data for research during my endoscopy at NIH or CHU Gabriel Toure.
Born in the African continent and of African ancestry
See 2 more

Exclusion Criteria

I have used Dupixent in the last 6 months.
I haven't taken biologic meds like Nucala or Fasenra recently.
Pregnancy
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Esophageal String Test

Participants undergo the esophageal string test to collect esophageal secretions for diagnostic analysis

1 hour
1 visit (in-person)

Endoscopic Exam

Participants have an endoscopic exam to take tissue samples from the esophagus, stomach, and small intestine

1 visit
1 visit (in-person)

Follow-up

Participants have a final visit to discuss test results and complete a survey

1 visit
1 visit (in-person, online, or by phone)

What Are the Treatments Tested in This Trial?

Interventions

  • Esophageal String Test
Trial Overview The study aims to see if the Esophageal String Test (EST), which involves swallowing a capsule with a string that collects digestive fluid samples, can diagnose Eosinophilic Esophagitis (EoE) as an alternative to endoscopy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Esophageal string testExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

One-Hour Esophageal String TestEighty-seven percent of children, 95% of parents, and 92% of adults preferred the EST over endoscopy if it provided similar information. DISCUSSION: The 1-hour ...
Study Details | NCT02008903 | Esophageal String Test in ...The overall goal of this study is to develop a novel minimally invasive device, the Esophageal String Test (EST) to monitor esophageal inflammation during ...
Implementation of the esophageal string test in clinical ...The EST had moderate diagnostic accuracy (AUC = 0.83; sensitivity = 0.80; specificity = 0.75) in patients with known EoE. Our center has ...
Utilization and impact of esophageal string testing in ...The 1‐h esophageal string test (EST) is a minimally invasive test that can be used to monitor eosinophilic esophagitis (EoE) disease activity and guide.
Noninvasive tests for eosinophilic esophagitisIn this review, we will summarize the existing literature for several promising minimally invasive tests to measure disease activity in EoE.
Esophageal String TestingAn esophageal string test (EST) is a minimally invasive test for children with eosinophilic esophagitis (EoE.) Learn more about this innovative testing.
Esophageal String Test Monitoring to Monitor Eosinophilic ...The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy.
Esophageal String Test in Eosinophilic ...The overall goal of this study is to develop a novel minimally invasive device, the Esophageal String Test (EST) to monitor esophageal ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security