Testing a new method for diagnosing Helicobacter pylori infections
A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
This study is testing a new way to find Helicobacter pylori infections using a string test to see if it works better than the usual methods for people who have ongoing infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06871579 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the esophageal string test (EST) in detecting Helicobacter pylori infections compared to standard diagnostic methods. Participants aged 18 and older with persistent H. pylori infections will undergo the EST, which involves swallowing a capsule attached to a string that will collect samples from the stomach. The study will assess the sensitivity of the EST in identifying H. pylori and its ability to detect antibiotic resistance. Participants will also receive treatment based on the results of the EST and undergo follow-up testing to evaluate treatment success.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have a persistent H. pylori infection after at least one course of treatment.
Not a fit: Patients who are pregnant, have recently taken antibiotics, or have certain gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and less invasive method for diagnosing H. pylori infections and determining antibiotic resistance.
How similar studies have performed: While the EST is a novel approach, similar diagnostic methods have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 H. pylori infection (by endoscopy, stool antigen, or urea breath testing) * 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 * 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Amy D Klion, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Michelle M Luera
- Email: michelle.luera@nih.gov
- Phone: (240) 236-9276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.