Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
2 other identifiers
interventional
25
1 country
1
Brief 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. ...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2025
CompletedStudy Start
First participant enrolled
June 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
April 27, 2026
April 20, 2026
1.6 years
March 11, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of the study population identified positive for H. pylori in EST eluates by PCR.
To assess the sensitivity of the gastric portion of the EST in detecting H. pylori infection.
Baseline
Secondary Outcomes (1)
Detection of H. pylori antibiotic resistance genes in EST eluates.
Baseline
Study Arms (1)
EnteroTracker(R) EST
EXPERIMENTALEsophageal string test device consists of a gelatin-coated capsule with a collection string wrapped inside.
Interventions
The device consists of a gelatin-coated capsule with a collection string wrapped inside.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (2)
Li Y, Lv T, He C, Wang H, Cram DS, Zhou L, Zhang J, Jiang W. Evaluation of multiplex ARMS-PCR for detection of Helicobacter pylori mutations conferring resistance to clarithromycin and levofloxacin. Gut Pathog. 2020 Jul 10;12:35. doi: 10.1186/s13099-020-00373-6. eCollection 2020.
PMID: 32670416BACKGROUNDHan X, Yu X, Gao X, Wang X, Tay CY, Wei X, Lai B, Marshall BJ, Zhang X, Chua EG. Quantitative PCR of string-test collected gastric material: A feasible approach to detect Helicobacter pylori and its resistance against clarithromycin and levofloxacin for susceptibility-guided therapy. Helicobacter. 2023 Aug;28(4):e12985. doi: 10.1111/hel.12985. Epub 2023 Apr 17.
PMID: 37066609BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy D Klion, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 12, 2025
Study Start
June 11, 2025
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
January 30, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04-20