RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

Official Title

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

Quick Facts

Study Start:2025-04-10
Study Completion:2026-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06871579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged \>=18 years
  2. * Diagnosed with persistent H. pylori infection (by endoscopy, stool antigen, or urea breath testing) after at least one course of antimicrobial therapy
  3. * Agreement to adhere to lifestyle considerations throughout study duration
  4. * Ability of participant to provide informed consent
  1. * Pregnancy or lactation
  2. * Use of antibiotics with activity against H. pylori within 4 weeks of enrollment
  3. * Anaphylaxis to amoxicillin, tetracycline, clarithromycin, metronidazole, or levofloxacin
  4. * Inability to swallow pills
  5. * 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

Contacts and Locations

Study Contact

Perla M Adames Castillo, R.N.
CONTACT
(301) 402-8495
perla.adamescastillo@nih.gov
Amy D Klion, M.D.
CONTACT
(301) 435-8903
aklion@niaid.nih.gov

Principal Investigator

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

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-10
Study Completion Date2026-03-30

Study Record Updates

Study Start Date2025-04-10
Study Completion Date2026-03-30

Terms related to this study

Keywords Provided by Researchers

  • Helicobacter Pylori
  • Antibiotic resistance
  • DIAGNOSTIC TEST

Additional Relevant MeSH Terms

  • Helicobacter Pylori