Esophageal String Test for Helicobacter Pylori
Trial Summary
What is the purpose of this trial?
Background: Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori. Objective: To compare the esophageal string test (EST) to standard tests for detecting H. pylori infection. Eligibility: People aged 18 years or older with persistent H. pylori infection. Design: Participants will have 3 or 4 clinic visits over 2 to 4 months. Screening visit: Participants will have a physical exam. They will provide a stool sample. Baseline visit: Participants will have blood tests. Then they will have the EST: One end of a string will be taped to the outside of their cheek; the other end will be packed into a capsule. Participants will swallow the capsule, and the string will unwind down their throat into their stomach. The string will be left in for at least 1 hour. Then researchers will gently pull out the string. The fluids soaked into the string will be studied. Some participants will be prescribed antibiotics. Follow-up visit 1: Participants whose H. pylori infection was cured by the antibiotics may leave the study. Those who are still infected will have an endoscopy: A flexible tube will be inserted down the throat and into the stomach. It will take tissue samples from the stomach lining. These participants will then receive antibiotics again. Follow-up visit 2: The physical exam, blood test, and stool sample will be repeated. ...
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used antibiotics that work against H. pylori within 4 weeks of joining the study.
What data supports the effectiveness of the Esophageal String Test (EST) treatment for Helicobacter pylori?
The Esophageal String Test (EST) is a minimally invasive method that can effectively collect samples for detecting Helicobacter pylori, showing a sensitivity of 75% and a specificity of 100% in one study. It is simpler and causes less discomfort compared to traditional endoscopy, making it a useful alternative for obtaining bacterial samples for culture and antibiotic susceptibility testing.12345
How does the Esophageal String Test for Helicobacter Pylori differ from other treatments?
The Esophageal String Test is unique because it is a non-invasive diagnostic method that involves swallowing a string to collect samples from the esophagus, which can then be analyzed for Helicobacter Pylori, unlike traditional treatments that typically involve medication to eradicate the bacteria.678910
Research Team
Amy D Klion, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
This trial is for adults over 18 with persistent Helicobacter pylori infection, which can cause stomach issues and ulcers. Participants will undergo several clinic visits, including physical exams and providing stool samples.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants will have blood tests and undergo the esophageal string test (EST) for H. pylori detection
Follow-up
Participants whose H. pylori infection was cured may leave the study. Those still infected will have an endoscopy and receive antibiotics again
Follow-up 2
Physical exam, blood test, and stool sample will be repeated to assess cure
Treatment Details
Interventions
- Esophageal String Test (EST)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor