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Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
Sponsor: VA Office of Research and Development
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).
Official title: Randomized Clinical Trial of Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans: "VA Eradicate HP"
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-07-01
Completion Date
2030-06-30
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Bismuth quadruple therapy with optimized PPI
Bismuth 524mg QID, Metronidazole 500mg QID, Tetracycline 500MG QID, and Omeprazole 20 mg QID for 14 days.
Bismuth quadruple therapy with standard PPI
Bismuth 524mg QID, Metronidazole 500mg QID, Tetracycline 500mg QID, and Omeprazole 20mg (active BID + placebo BID) for 14 days. \*\*NOTE: placebo tablets are used to maintain the same number of pills in all study arms and preserve blinding
Clarithromycin triple therapy with optimized PPI
Amoxicillin 1000mg (active BID + placebo BID), Clarithromycin 500mg (active BID + placebo BID), and Omeprazole 20mg QID for 14 days. \*\*NOTE: placebo tablets are used to maintain the same number of pills in all study arms and preserve blinding
Clarithromycin triple therapy with standard PPI
Amoxicillin 1000mg (active BID + placebo BID), Clarithromycin 500mg (active BID + placebo BID), and Omeprazole 20mg (active BID + placebo BID) for 14 days. \*\*NOTE: placebo tablets are used to maintain the same number of pills in all study arms and preserve blinding
Standard bismuth quadruple therapy
Bismuth 524mg QID, Metronidazole 500mg QID, Tetracycline 500mg QID, and Omeprazole 20mg (active BID + placebo BID) for 14 days. \*\*NOTE: placebo tablets are used to maintain the same number of pills in all study arms and preserve blinding
Locations (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States