Helicobacter PyloriPhase 3VA EradicateHPNCT07104318
Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
A Phase 3 study testing Bismuth quadruple therapy with optimized proton pump inhibitor (PPI), Bismuth quadruple therapy with standard proton pump inhibitor (PPI) and Clarithromycin triple therapy with optimized proton pump inhibitor (PPI) in people with Helicobacter Pylori, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Bismuth quadruple therapy with optimized proton pump inhibitor (PPI), Bismuth quadruple therapy with standard proton pump inhibitor (PPI) and Clarithromycin triple therapy with optimized proton pump inhibitor (PPI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Veterans, 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
Who cannot join
- The investigators will exclude individuals with:
- Severe gastrointestinal (GI) symptoms that limit the ability to tolerate study medications. Note: The presence of symptoms or gastrointestinal 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 as Los Angeles Classification C or D esophagitis
- Allergy or severe intolerance/contraindication to any of the treatment components. Note: In patients with penicillin allergy, metronidazole is often substituted for amoxicillin in PPI clarithromycin triple therapy. However, this alternative regimen demonstrates higher failure rates vs. PPI-clarithromycin triple therapy with amoxicillin among Veterans and thus the investigators elected to exclude patients with penicillin allergy.
- Severe medical comorbidity that is a threat to life. This includes, but is not limited to, coronary artery disease with myocardial infarction or equivalent (e.g., cerebrovascular event) within 12 months, unstable angina or congestive heart failure, cardiac or vascular stent placement within 12 months, chronic obstructive pulmonary disease requiring home oxygen, decompensated cirrhosis, end-stage renal disease, other diseases that limit life expectancy to less than 5 years.
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- Any prior history of upper gastrointestinal surgery or gastric cancer diagnosis
- Past liver transplant or allogenic bone marrow transplant, given that pharmacogenomic testing is inaccurate for these patients
- Any history of recurrent Clostridioides difficile infection (CDI), defined as an episode of CDI occurring within 8 weeks of a previous CDI episode; or any episode of CDI within the preceding 12 months
- Evidence of any overt gastrointestinal bleeding
- History of photosensitive reactions to any medications
- Women who are pregnant, lactating, or of childbearing age without reliable contraception (Note: all women of childbearing age will be asked to submit a urine pregnancy test prior to enrollment)
- Prior CYP2C19 or PHASER testing or HP antimicrobial susceptibility profiling before enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Shailja Shah, MD MPH, (858) 552-8585, shailja.shah@va.gov
Shailja Shah, MD MPH
About this study
Official title: Randomized Clinical Trial of Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans: "VA Eradicate HP"
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
- Being tested
- Bismuth quadruple therapy with optimized proton pump inhibitor (PPI), Bismuth quadruple therapy with standard proton pump inhibitor (PPI), Clarithromycin triple therapy with optimized proton pump inhibitor (PPI), Clarithromycin triple therapy with standard PPI, Standard bismuth quadruple therapy
- Keywords
- Helicobacter pylori, H. pylori, Randomized Intervention Study, CYP2C19, antibiotic susceptibility, personalized treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth quadruple therapy with optimized proton pump inhibitor (PPI)Drug
Bismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams QID for 14 days.
Bismuth quadruple therapy with standard proton pump inhibitor (PPI)Drug
Bismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams (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 proton pump inhibitor (PPI)Drug
Amoxicillin 1000 milligrams (active BID + placebo BID), Clarithromycin 500 milligrams (active BID + placebo BID), and Omeprazole 20 milligrams 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 PPIDrug
Amoxicillin 1000 milligrams (active BID + placebo BID), Clarithromycin 500 milligrams (active BID + placebo BID), and Omeprazole 20 milligrams (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 therapyDrug
Bismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams (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
| Study group | Role | What they receive |
|---|---|---|
| Personalized bismuth-based quadruple therapy or clarithromycin triple therapy | Experimental | Participants allocated to the experimental group receive a personalized treatment based on clarithromycin (CLR) and amoxicillin susceptibility and CYP2C19 metabolizer profile status as follows:
1. CLR or amoxicillin resistant/CYP2C19 normal/rapid/ultrarapid metabolizers receive bismuth quadruple therapy (BQT) with optimized PPI (bismuth 524 milligrams QID, metronidazole 500 milligrams QID, tetracycline 500 milligrams QID, and omeprazole 20 milligrams QID) for 14 days.
2. CLR or amoxicillin resistant/CYP2C19 intermediate/poor metabolizers receive BQT with standard PPI (BQT + omeprazole 20 mg BID) for 14 days.
3. CLR and amoxicillin susceptible/CYP2C19 normal/rapid/ultrarapid metabolizers receive CLR triple therapy with optimized PPI (amoxicillin 1000 mg BID, clarithromycin 500mg BID, and omeprazole 20mg QID) for 14 days.
4. CLR and amoxicillin susceptible/CYP2C19 intermediate/poor metabolizers receive CLR triple therapy with standard PPI (CLR triple therapy + omeprazole 20mg BID). Receives: Drug: Bismuth quadruple therapy with optimized proton pump inhibitor (PPI); Drug: Bismuth quadruple therapy with standard proton pump inhibitor (PPI); Drug: Clarithromycin triple therapy with optimized proton pump inhibitor (PPI); Drug: Clarithromycin triple therapy with standard PPI |
| Standard bismuth-based quadruple therapy | Active comparator | Participants allocated to this group receive standard bismuth-based quadruple therapy (BQT), which is first-line treatment according to US clinical guidelines. BQT consists of bismuth subsalicylate 524 milligrams QID (or bismuth subcitrate if salicylate allergy), tetracycline 500 milligrams QID, metronidazole 500 milligrams QID, and twice daily standard dose PPI (omeprazole 20 milligrams BID) for 14 days. Receives: Drug: Standard bismuth quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication success
The primary outcome is H. pylori eradication success, defined as negative post-treatment H. pylori stool antigen (HPsAg) testing. Post-treatment persistent positive HPsAg indicates eradication treatment failure; equivocal tests will be conservatively counted as a treatment failure, along with participants who fail to complete follow up testing within the prespecified timeframe (intention-to-treat analysis). All participants must be off proton pump inhibitors (PPIs) for a minimum of 2 weeks, and off antibiotics or bismuth for at least 4 weeks prior to HPsAg testing. HPsAg testing will be performed between 4-6 weeks post-treatment.
Measured: 4-6 weeks after treatment
Secondary outcomes (2)
Treatment adherence
Patient-reported treatment adherence will be evaluated using the validated Adherence to Refills and Medications Scale (ARMS) and pill counts obtained during telephone interviews conducted in weeks 1 and 2 following treatment initiation. Adherence will be defined as >90% of the treatment regimen consumed.
Measured: Weeks 1 and 2 after treatment initiation
Treatment-emergent side effects/adverse events
Participant-reported side effects and adverse events will be collected during telephone interviews conducted in weeks 1 and 2 following treatment initiation, and in week 6 following treatment completion. Treatment-emergent adverse events will be classified using the Medical Dictionary for Regulatory Activities terminology (MedDRA).
Measured: Weeks 1 and 2 after treatment initiation, 6 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jan 2027 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- San Diego Veterans Healthcare System
- Responsible party
- Sponsor
- Investigators
- Shailja Shah, MD MPH, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104318
- Sponsor's protocol ID
- INFB-001-25S
- Other IDs
- 1I01RD001530-01A2, H230142
- Acronym
- VA EradicateHP
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans: "VA Eradicate HP"
- ClinicalTrials.gov ID
- NCT07104318
- Acronym / sponsor ID
- VA EradicateHP / INFB-001-25S
- Conditions
- Helicobacter Pylori
- Keywords
- Helicobacter pylori, H. pylori, Randomized Intervention Study, CYP2C19, antibiotic susceptibility, personalized treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- San Diego Veterans Healthcare System
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized bismuth-based quadruple therapy or clarithromycin triple therapy | Experimental | Drug: Bismuth quadruple therapy with optimized proton pump inhibitor (PPI), Drug: Bismuth quadruple therapy with standard proton pump inhibitor (PPI), Drug: Clarithromycin triple therapy with optimized proton pump inhibitor (PPI), Drug: Clarithromycin triple therapy with standard PPIParticipants allocated to the experimental group receive a personalized treatment based on clarithromycin (CLR) and amoxicillin susceptibility and CYP2C19 metabolizer profile status as follows: 1. CLR or amoxicillin resistant/CYP2C19 normal/rapid/ultrarapid metabolizers receive bismuth quadruple therapy (BQT) with optimized PPI (bismuth 524 milligrams QID, metronidazole 500 milligrams QID, tetracycline 500 milligrams QID, and omeprazole 20 milligrams QID) for 14 days. 2. CLR or amoxicillin resistant/CYP2C19 intermediate/poor metabolizers receive BQT with standard PPI (BQT + omeprazole 20 mg BID) for 14 days. 3. CLR and amoxicillin susceptible/CYP2C19 normal/rapid/ultrarapid metabolizers receive CLR triple therapy with optimized PPI (amoxicillin 1000 mg BID, clarithromycin 500mg BID, and omeprazole 20mg QID) for 14 days. 4. CLR and amoxicillin susceptible/CYP2C19 intermediate/poor metabolizers receive CLR triple therapy with standard PPI (CLR triple therapy + omeprazole 20mg BID). |
| Standard bismuth-based quadruple therapy | Active comparator | Drug: Standard bismuth quadruple therapyParticipants allocated to this group receive standard bismuth-based quadruple therapy (BQT), which is first-line treatment according to US clinical guidelines. BQT consists of bismuth subsalicylate 524 milligrams QID (or bismuth subcitrate if salicylate allergy), tetracycline 500 milligrams QID, metronidazole 500 milligrams QID, and twice daily standard dose PPI (omeprazole 20 milligrams BID) for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Veterans, 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
Key exclusion criteria (13 listed)
- Severe gastrointestinal (GI) symptoms that limit the ability to tolerate study medications. Note: The presence of symptoms or gastrointestinal 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 as Los Angeles Classification C or D esophagitis
- Allergy or severe intolerance/contraindication to any of the treatment components. Note: In patients with penicillin allergy, metronidazole is often substituted for amoxicillin in PPI clarithromycin triple therapy. However, this alternative regimen demonstrates higher failure rates vs. PPI-clarithromycin triple therapy with amoxicillin among Veterans and thus the investigators elected to exclude patients with penicillin allergy.
- Severe medical comorbidity that is a threat to life. This includes, but is not limited to, coronary artery disease with myocardial infarction or equivalent (e.g., cerebrovascular event) within 12 months, unstable angina or congestive heart failure, cardiac or vascular stent placement within 12 months, chronic obstructive pulmonary disease requiring home oxygen, decompensated cirrhosis, end-stage renal disease, other diseases that limit life expectancy to less than 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bismuth quadruple therapy with optimized proton pump inhibitor (PPI)Bismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams QID for 14 days. | Drug | Personalized bismuth-based quadruple therapy or clarithromycin triple therapy |
| Bismuth quadruple therapy with standard proton pump inhibitor (PPI)Bismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams (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 | Personalized bismuth-based quadruple therapy or clarithromycin triple therapy |
| Clarithromycin triple therapy with optimized proton pump inhibitor (PPI)Amoxicillin 1000 milligrams (active BID + placebo BID), Clarithromycin 500 milligrams (active BID + placebo BID), and Omeprazole 20 milligrams QID for 14 days. **NOTE: placebo tablets are used to maintain the same number of pills in all study arms and preserve blinding | Drug | Personalized bismuth-based quadruple therapy or clarithromycin triple therapy |
| Clarithromycin triple therapy with standard PPIAmoxicillin 1000 milligrams (active BID + placebo BID), Clarithromycin 500 milligrams (active BID + placebo BID), and Omeprazole 20 milligrams (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 | Personalized bismuth-based quadruple therapy or clarithromycin triple therapy |
| Standard bismuth quadruple therapyBismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams (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-based quadruple therapy |
Primary outcome
H. pylori eradication success
Time frame: 4-6 weeks after treatment
The primary outcome is H. pylori eradication success, defined as negative post-treatment H. pylori stool antigen (HPsAg) testing. Post-treatment persistent positive HPsAg indicates eradication treatment failure; equivocal tests will be conservatively counted as a treatment failure, along with participants who fail to complete follow up testing within the prespecified timeframe (intention-to-treat analysis). All participants must be off proton pump inhibitors (PPIs) for a minimum of 2 weeks, and off antibiotics or bismuth for at least 4 weeks prior to HPsAg testing. HPsAg testing will be performed between 4-6 weeks post-treatment.
2 secondary outcomes
Treatment adherence
Time frame: Weeks 1 and 2 after treatment initiation
Treatment-emergent side effects/adverse events
Time frame: Weeks 1 and 2 after treatment initiation, 6 weeks after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shailja Shah, MD MPH principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bismuth quadruple therapy with optimized proton pump inhibitor (PPI), Bismuth quadruple therapy with standard proton pump inhibitor (PPI) and Clarithromycin triple therapy with optimized proton pump inhibitor (PPI) in people with Helicobacter Pylori, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shailja Shah, MD MPH ((858) 552-8585, shailja.shah@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication success (time frame: 4-6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.