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Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

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Summary

NIH's ClinicalTrials.gov has registered a new Phase 4 clinical trial (NCT07533422) evaluating fecal-based antimicrobial resistance gene testing to guide personalized Helicobacter pylori rescue therapy. The study will enroll patients who have failed initial treatment and compare personalized treatment based on fecal resistance profiles against conventional quadruple therapy, measuring eradication rates and safety outcomes.

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What changed

A new clinical trial registration has been published on ClinicalTrials.gov for a study investigating whether fecal-based antimicrobial resistance gene testing can improve personalized rescue therapy for Helicobacter pylori infection. The trial will compare personalized treatment selected based on fecal resistance profiles against conventional quadruple therapy, assessing eradication rates and safety as primary endpoints.

For healthcare providers and researchers, this registry entry signals emerging interest in non-invasive diagnostic approaches for guiding antibiotic therapy in H. pylori treatment failures. The study addresses limitations of conventional susceptibility testing that requires invasive endoscopy and bacterial culture.

Archived snapshot

Apr 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

N/A NCT07533422 Kind: NA Apr 16, 2026

Abstract

Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive, rapid and accurate, thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.

Conditions: HELICOBACTER PYLORI INFECTIONS, Rescue Therapy for Helicobacter Pylori

Interventions: Personalized treatment based on the results of fecal antimicrobial resistance gene testing, Conventional Quadruple Therapy

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533422

Who this affects

Applies to
Healthcare providers
Industry sector
6221 Hospitals & Health Systems
Activity scope
Clinical trial registration Diagnostic testing Antimicrobial therapy
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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