Personalized Treatment for Helicobacter Pylori

(VA EradicateHP Trial)

Not yet recruiting at 1 trial location

Overseen By Shailja Shah, MD MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Must be taking: Proton pump inhibitors

Disqualifiers: Severe GI symptoms, Active PUD, Penicillin allergy, Severe comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether a personalized treatment plan is more effective than the usual bismuth-based quadruple therapy (BQT) in eliminating H. pylori, a stomach bacteria that can cause ulcers and other issues. Participants will either receive a customized treatment based on their specific antibiotic needs and metabolism or follow the standard BQT. The trial will also assess treatment adherence, tolerability, and any side effects. Veterans who have tested positive for H. pylori and have not previously received treatment may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be able to stop taking proton pump inhibitors (PPIs) for two weeks for accurate testing. If you have conditions that require continuous PPI use, you may not be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bismuth quadruple therapy (BQT) is generally well-tolerated. One study found that using BQT for 14 days successfully treated up to 96% of H. pylori infections, indicating its effectiveness and safety. However, some individuals might experience side effects like nausea or diarrhea, which are common with antibiotics.

For clarithromycin triple therapy, research indicates it is safe, but its success rate can drop below 90% due to increasing antibiotic resistance. Side effects may include stomach issues, similar to those with BQT.

Both treatments have been widely used and maintain a good safety record. However, individual reactions to medications can vary, and side effects may differ. It is always important to discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the personalized treatment for Helicobacter pylori because it tailors therapy based on individual patient profiles, something standard treatments don't do. Unlike the traditional one-size-fits-all approach, this method considers a patient's specific resistance to drugs like clarithromycin and amoxicillin and their CYP2C19 metabolizer status. By doing so, it optimizes the effectiveness of either bismuth quadruple therapy or clarithromycin triple therapy, potentially increasing treatment success and minimizing unnecessary side effects. This personalized strategy offers a more precise and potentially more effective way to tackle H. pylori infections.

What evidence suggests that this trial's treatments could be effective for Helicobacter pylori?

Studies have shown that bismuth quadruple therapy (BQT) effectively treats H. pylori, with success rates often exceeding 90%. It is recommended for patients who have not previously received treatment for H. pylori. Research suggests that a 14-day course of BQT is a strong option for eradicating this infection. In contrast, clarithromycin triple therapy has mixed success rates and is only recommended when tests indicate it is likely to be effective, particularly when the bacteria are sensitive to the antibiotics used. This trial will compare personalized treatments, where participants may receive either a personalized bismuth-based quadruple therapy or clarithromycin triple therapy, with standard bismuth-based quadruple therapy. Personalized treatments, like those being tested, might yield better results by tailoring medication to each person's specific needs. ^{1 2 3 4 6}

Who Is on the Research Team?

Shailja Shah, MD MPH

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for treatment-naïve Veterans with active Helicobacter pylori infection confirmed by a stool test. Participants must be able to provide informed consent and follow the study protocol, including taking medications and attending follow-up calls.

Inclusion Criteria

Subjects who can understand and sign written informed consent

I am a veteran aged 18 or older.

I have an active H. pylori infection confirmed by a stool test or other methods.

Exclusion Criteria

History of photosensitive reactions to any medications

I have severe stomach issues that may stop me from taking study drugs.

Conditions where urgent H. pylori treatment is recommended

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 14-day personalized H. pylori treatment regimen or a standard 14-day empiric BQT regimen

2 weeks

Baseline visit for sample collection, followed by telephone interviews during weeks 1 and 2

Follow-up

Participants are monitored for adherence and adverse events, and H. pylori eradication is assessed

4-6 weeks

Telephone interviews at weeks 1, 2, and 6; post-treatment stool antigen test at week 8

What Are the Treatments Tested in This Trial?

Interventions

• Bismuth quadruple therapy
• Clarithromycin triple therapy

Trial Overview The trial compares two treatments for H. pylori: personalized therapy based on individual drug metabolism and bacteria susceptibility versus standard bismuth quadruple therapy. It's a double-blinded study where participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

Group I: Personalized bismuth-based quadruple therapy or clarithromycin triple therapy Experimental Treatment 4 Interventions

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 524mg QID, metronidazole 500mg QID, tetracycline 500MG QID, and omeprazole 20 mg QID) for 14 days. 2. CLR or amoxicillin resistant/CYP2C19 intermediate/poor metabolizers receive BQT with standard PPI (BQT + omeprazole 20mg BID) for 14 days. 3. CLR and amoxicillin susceptible/CYP2C19 normal/rapid/ultrarapid metabolizers receive CLR triple therapy with optimized PPI (amoxicillin 1000mg 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).

Group II: Standard bismuth-based quadruple therapy Active Control 1 Intervention

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 524mg QID (or bismuth subcitrate if salicylate allergy), tetracycline 500mg QID, metronidazole 500mg QID, and twice daily standard dose PPI (omeprazole 20mg BID) for 14 days.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

San Diego Veterans Healthcare System

Collaborator

Trials

38

Recruited

5,500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40619293/

Efficacy and safety of ten-day bismuth quadruple therapy ... The efficacy of 10-day bismuth quadruple therapy as a first-line treatment for H. pylori was comparable between elderly and non-elderly ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1684118225001318

Efficacy and safety of ten-day bismuth quadruple therapy ... The efficacy of 10-day bismuth quadruple therapy as a first-line treatment for H. pylori was comparable between elderly and non-elderly cohorts, ...

3. gut.bmj.com gut.bmj.com/content/74/1/15

Evolution of the use, effectiveness and safety of bismuth ... - Gut A rate of effectiveness above 90% was obtained with 10-day single-capsule bismuth quadruple therapy containing tetracycline and metronidazole. When antibiotics ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00108-1/fulltext

10-Day versus 14-day bismuth quadruple therapy for first- ... The efficacy of 10-day bismuth quadruple therapy was found to be non-inferior to that of 14-day bismuth quadruple therapy as a first-line anti-H ...

5. gi.org gi.org/journals-publications/ebgi/schoenfeld_sep2024/

ACG Guideline on Treatment of Helicobacter pylori Optimized bismuth-based quadruple therapy for 14 days is the recommended therapy for treatment-naïve patients (Figure 1, Table 1) as well as ...

6. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s2317_efficacy_and_safety_of_10_day_vs_14_day.2318.aspx

S2317 Efficacy and Safety of 10-day vs 14-day Bismuth- ... The per-protocol eradication rates were 90.8% for the 10-day BQT group and 96.0% for 14-day BQT. There was no significant difference between the eradication ...