Not Yet RecruitingPhase 3

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

United States360 participantsStarted 2026-07-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult Veterans ages 18 years or older, irrespective of sex/gender (male, female, non-binary, other preferred classification). * Treatment-naïve patients with active H. pylori infection as determined by a positive H. pylori stool antigen (HPsAg), gastric biopsy, or urease breath test. All individuals who test positive based on a non-HPsAg modality will need to have a positive HPsAg documented within 4 weeks of enrollment to be considered eligible. * Subjects who can understand and sign written informed consent. Exclusion Criteria: The investigators will exclude individuals with: * Severe gastrointestinal (GI) symptoms that limit the ability to tolerate study medications. Note: The presence of symptoms or GI diagnoses such as irritable bowel syndrome or gastroesophageal reflux does not impact H. pylori eradication and will not be exclusion criteria unless deemed that symptom severity will impact adherence. * Conditions where urgent H. pylori treatment is recommended (i.e., active peptic ulcer disease (PUD) complicated by bleeding, perforation, or obstruction; gastric neoplasia including MALT lymphoma). Active PUD is defined as having a gastric or duodenal ulcer confirmed on an upper endoscopic procedure in the 4 weeks prior to eligibility determination. * Inability to be safely off of PPI for two weeks to allow for accurate post-treatment HPsAg testing. These conditions include Barrett's esophagus with dysplasia, active PUD, severe esophagitis defined …

What they're measuring

H. pylori eradication success

Timeframe: 4-6 weeks after treatment

Trial details

NCT IDNCT07104318

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2029-06-30

Contact for this trial

Shailja Shah, MD MPH

(858) 552-8585 shailja.shah@va.gov