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

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).

Conditions

• Helicobacter Pylori

Interventions

DRUG

Bismuth quadruple therapy with optimized PPI

Bismuth 524mg QID, Metronidazole 500mg QID, Tetracycline 500MG QID, and Omeprazole 20 mg QID for 14 days.

DRUG

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

DRUG

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

DRUG

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

DRUG

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

Sponsors & Collaborators

• San Diego Veterans Healthcare System

  collaborator FED

• VA Office of Research and Development

  lead FED

Principal Investigators

• Shailja Shah, MD MPH · VA San Diego Healthcare System, San Diego, CA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2029-06-30

Completion

2030-06-30

FDA Drug

Yes

Countries

• United States

Study Locations