Helicobacter Pylori Infection
Conditions
Brief summary
Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.
Interventions
DRUGVonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg
Participants will receive the respective drug regimens twice daily. The Vonoprazan triple therapy arm will administer Vonoprazan 20 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily. The Standard triple therapy arm will administer Esomeprazole 40 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult (18 years - 80 years) * Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer * 13C-urea breath test (UBT) positive/ Rapid urease test positive (RUT) on endoscopic biopsy * Off PPIs for 2 weeks
Exclusion criteria
* Penicillin allergy * Recent use of antibiotics in the past 1 month * Previous H. pylori therapy * Intestinal metaplasia, gastric cancer, bleeding peptic ulcer * Patient who is unable to understand study protocol or not consenting * Pregnancy, lactation * Patient on anticoagulation, NSAIDs * Patient using drugs with interactions with vonoprazan, amoxicillin, clarithromycin or PPIs * Cirrhosis, Chronic kidney disease, chronic lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A randomised controlled trial comparing Vonoprazan triple therapy (Vonoprazan, Amoxicillin, Clarithromycin), and standard triple therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter pylori eradication in Indian population. VECTOR trial | 1 year | The primary outcome measurement is to assess the eradication of H. pylori i.e. negative UBT or stool antigen test 4 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse events and eradication rates in antibiotic-resistant strains. | 1 year | Assessment of adverse events and eradication rates in antibiotic-resistant strains. |
Countries
India
Contacts
Primary ContactKrithi Krishna Koduri Doctor
Outcome results
None listed