Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT06871579

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-27

25

Participants Needed

1

Research Sites

85 weeks

Total Duration

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AI-Summary

What this Trial Is About

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. ...

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Diagnosed with H. pylori infection by endoscopy, stool antigen, or urea breath test
  • Agree to follow lifestyle considerations during the study
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Used antibiotics active against H. pylori within 4 weeks before enrollment
  • Unable to swallow pills
  • Have biopsy-proven high grade dysplastic Barrett's esophagus, active peptic ulcer disease, recent upper gastrointestinal bleeding within 4 weeks, Zollinger Ellison syndrome, or history of gastric bypass surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Michelle M Luera

CONTACT

A

Amy D Klion, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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