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NCT07104318 · ClinicalTrials.gov registry record · Phase 3
Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
A Phase 3 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
NCT07104318: Clinical Trial Phase 3 study, sponsored by VA Office of Research and Development.
NCT07104318 is a Phase 3 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 360 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07104318, a Phase 3 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the Helicobacter pylori (H. pylori) eradication rate following empiric bismuth-based quadruple therapy (BQT) versus a personalized H. pylori treatment strategy in treatment-naïve Veterans with confirmed H. pylori infection. This study is an eight-week, parallel two-arm, double-blinded, prospective, single-site randomized clinical trial designed to test the hypothesis that personalized H. pylori therapy achieves higher eradication rates compared to the standard empiric BQT regimen. Secondary outcomes include comparisons of treatment adherence, tolerability, and the incidence of treatment-related side effects and adverse events between the two groups. A total of 360 treatment-naïve Veterans with active H. pylori infection, confirmed by a positive H. pylori stool antigen test (HPsAg), will be enrolled, randomized, and analyzed at the VA San Diego Healthcare System (VASDHS). Participants who meet eligibility criteria and provide informed consent will be randomized in a 1:1 ratio to receive either a 14-day personalized H. pylori treatment regimen (n=180) or a standard 14-day empiric BQT regimen (n=180). Participants randomized to personalized therapy will receive H. pylori treatment that incorporates 1) standard or optimized proton pump inhibitor (PPI) dosing according to participants' CYP2C19 metabolizer phenotype, and 2) tailored antibiotics according to participants' noninvasive (stool) H. pylori antibiotic susceptibility testing (AST). All participants will complete a baseline questionnaire and provide pre-treatment stool and blood samples for H. pylori AST and serum CYP2C19 testing, respectively. Follow-up will include brief telephone interviews during week 1 and week 2 of treatment and again two weeks post-treatment to assess adherence and monitor for adverse events. Cure will be assessed using a post-treatment stool antigen test (HPsAg) at week 8 (four weeks after completing therapy).
Interventions
- DRUG Bismuth quadruple therapy with optimized PPI
- DRUG Bismuth quadruple therapy with standard PPI
- DRUG Clarithromycin triple therapy with optimized PPI
- DRUG Clarithromycin triple therapy with standard PPI
- DRUG Standard bismuth quadruple therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07104318
The ClinicalTrials.gov registry entry for NCT07104318 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bismuth quadruple therapy with optimized PPI is the first listed.
NCT07104318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07104318 about?
NCT07104318 is a clinical study titled "Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans". The primary objective of this study is to compare the Helicobacter pylori (H. pylori) eradication rate following empiric bismuth-based quadruple therapy (BQT) versus a personalized H. pylori treatment strategy in treatment-naïve Veterans with confirmed H. pylori infection. This study is an eight-we...
What is the current status of trial NCT07104318?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2026-07-01. Estimated completion is 2030-06-30.
What interventions are being tested in trial NCT07104318?
The interventions under investigation include: Bismuth quadruple therapy with optimized PPI (DRUG), Bismuth quadruple therapy with standard PPI (DRUG), Clarithromycin triple therapy with optimized PPI (DRUG), Clarithromycin triple therapy with standard PPI (DRUG), Standard bismuth quadruple therapy (DRUG).
Who is sponsoring clinical trial NCT07104318?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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