Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new method called the esophageal string test (EST) to diagnose an infection caused by a bacterium called Helicobacter pylori (H. pylori). H. pylori can lead to serious health issues like stomach ulcers and even cancer. The researchers want to see how well the EST compares to standard tests used to detect this infection. To participate, individuals must be at least 18 years old and have a persistent H. pylori infection that has not improved after taking antibiotics.

Participants in the study can expect to attend several visits over a period of 2 to 4 months. During these visits, they will undergo a physical exam, provide blood and stool samples, and take part in the EST, which involves swallowing a capsule that contains a string. This string will collect fluids from the stomach, which will then be analyzed. Depending on the results, some participants may receive antibiotics again or undergo further testing with a flexible tube to take samples from the stomach lining. The study is currently recruiting participants of all genders who meet the eligibility criteria, so if you or someone you know has a persistent H. pylori infection, this could be an opportunity to help improve diagnosis methods.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• • Aged \>=18 years
• • Diagnosed with persistent H. pylori infection (by endoscopy, stool antigen, or urea breath testing) after at least one course of antimicrobial therapy
• • Agreement to adhere to lifestyle considerations throughout study duration
• • Ability of participant to provide informed consent
• EXCLUSION CRITERIA:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • Pregnancy or lactation
• • Use of antibiotics with activity against H. pylori within 4 weeks of enrollment
• • Anaphylaxis to amoxicillin, tetracycline, clarithromycin, metronidazole, or levofloxacin
• • Inability to swallow pills
• • Biopsy-proven high grade dysplastic Barrett s esophagus, active peptic ulcer disease, recent (within 4 weeks) upper GI bleed, and/or history of Zollinger Ellison syndrome or gastric bypass surgery