A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

• Status: Recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Helicobacter pylori (H. pylori) gastritis is a common bacterial infection among the elderly population. H. pylori infection causes chronic progressive gastric inflammation, peptic ulcer disease and gastric cancer. Gastric cancer is a significant contributor of cancer-related mortality. The eradication of H. pylori reduces the incidence of gastric cancer. However, the efficacy of H. pylori eradication has decreased dramatically because of antibiotic resistance. This study aims to (i) compare the eradication rates of H. pylori by triple therapy with vonoprazan for the treatment of H. pylori gastritis) (TTV regimen), with triple therapy with conventional proton pump inhibitor (PPI) (TTP regimen) in a multi-racial Asian cohort, (ii) evaluate the prevalence of antibiotic (klacid/amoxicillin/levofloxacin/tetracycline) resistance in H. pylori infected patients, and (iii) assess the safety of the TTV regimen. Diagnosed H. pylori-infected patients (n=252) will be enrolled and randomized 1:1 to TTV or TTP regimen. Gastric biopsies will be cultured and antibiotic sensitivity evaluated using E-test/agar dilution method. The safety of TTV regimen will be assessed using adverse effect questionnaire. This study may potentially impact on prescribing policies and management of H. pylori infections for improved therapeutic outcome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changi General Hospital
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole; Omeprazole; Proton Pump Inhibitors; Rabeprazole

Criteria

Inclusion Criteria:

• Newly diagnosed to have H. pylori infection from the Gastroenterology and Hepatology Clinic or ward from Changi General Hospital, The diagnosis of H. pylori infection is established based on either a positive carbon urea breath test (CUBT), a positive rapid urease test, or histology in patients who undergo a diagnostic upper gastrointestinal endoscopy.

• Asian (Chinese, Malay or Indian) ancestry as defined by NRIC,

• Aged ≥ 21 years of age,

• Provision of written informed consent,

• Willing to provide a blood sample for genotyping,

• Ability to communicate with the investigator and to understand and comply with all requirements of study participation.

Exclusion Criteria:

• Known allergy to any of the treatment drugs,

• Inability to undergo routine test to confirm success of H. pylori eradication,

• Previous failed H. pylori therapy,

• Pregnancy or lactation,

• Declare themselves positive for HIV or viral hepatitis (Hepatitis A, B, C),

• Treatment within the previous 3 months with antibiotics.