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Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans

Study acronym: VA EradicateHP
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Oct 1, 2026 to Jan 1, 2027 Interventions modified · Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 2 of 2 entries Show 3 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Start date: Jul 1, 2026 to Oct 1, 2026 Primary completion moved earlier from Jun 30, 2029 to Mar 31, 2029 · Completion moved earlier from Jun 30, 2030 to Mar 31, 2030 · Site contact updated · 1 morev6 Show 4 more changesShow less
    • Primary completion moved earlier from Jun 30, 2029 to Mar 31, 2029
    • Completion moved earlier from Jun 30, 2030 to Mar 31, 2030
    • Site contact updated
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Apr 1, 2026 to Jul 1, 2026 Primary completion date: Mar 31, 2029 to Jun 30, 2029 · Completion date: Mar 31, 2030 to Jun 30, 2030 · Site contact updatedv5 Show 3 more changesShow less
    • Primary completion date: Mar 31, 2029 to Jun 30, 2029
    • Completion date: Mar 31, 2030 to Jun 30, 2030
    • Site contact updated
  4. Start date: Jan 1, 2026 to Apr 1, 2026 Primary completion date: Dec 1, 2028 to Mar 31, 2029 · Completion date: Dec 1, 2029 to Mar 31, 2030 · Site contact updatedv4 Show 3 more changesShow less
    • Primary completion date: Dec 1, 2028 to Mar 31, 2029
    • Completion date: Dec 1, 2029 to Mar 31, 2030
    • Site contact updated
  5. Lead sponsor: San Diego Veterans Healthcare System to VA Office of Research and Development Primary completion date: Dec 2028 to Dec 1, 2028 · Completion date: Dec 2029 to Dec 1, 2029 · Start date: Jan 2026 to Jan 1, 2026 · 3 morev3 Show 6 more changesShow less
    • Primary completion date: Dec 2028 to Dec 1, 2028
    • Completion date: Dec 2029 to Dec 1, 2029
    • Start date: Jan 2026 to Jan 1, 2026
    • Eligibility criteria revised
    • Study site revised
    • Collaborators expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Eligibility criteria expanded, about 2 words Study title shortened, about 4 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07104318
Lead Sponsor VA Office of Research and Development
Collaborators: San Diego Veterans Healthcare System
Conditions Helicobacter Pylori
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov