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

NCT06871579 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-20

No results posted yet for this study

Summary

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

  • Helicobacter Pylori

Interventions

DIAGNOSTIC_TEST

EnteroTracker(R) EST

The device consists of a gelatin-coated capsule with a collection string wrapped inside.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Amy D Klion, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2027-01-30
Completion
2027-01-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06871579 on ClinicalTrials.gov