One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL

Aga Khan University

Status and phase: Enrolling; Phase 3

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Vonoprazan, Amoxicillin, Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05728424

2022-7002-21047

Details and patient eligibility

About

1. To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan.
2. To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.

Full description

Introduction: The overall aim of the study is to assess the efficacy of one week of Vonoprazan compared to two weeks of Vonoprazan in eradicating H-Pylori in patients with dyspeptic symptoms.

H. pylori is a pathogenic Gram-negative spiral bacillus that survives in the acid environment of the stomach. It is a leading cause of chronic gastritis, peptic ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. It is estimated that up to 50% of the total world population are infected with H. pylori. The prevalence of H. Pylori infection is currently rising in the developing world. Modified one-week triple therapy (two antibiotics for a week and a potassium-competitive acid blocker for 4-8 weeks) represents the most advanced prescribed regimen for H. pylori infection. With current and widely used therapeutic regimens, (such as two antibiotics and a proton pump inhibitor) there is a significant failure rate for the eradication of microorganism. Therefore, interventions that can improve H-pylori eradication along with improving patient's quality of life are highly important.

Vonoprazan is a potassium-competitive acid blocker, which inhibits the H+/K+ pump in the stomach. Unlike proton pump inhibitors, Vonoprazan inhibits the pump in a competitive and reversible manner. Hence, it is expected to be at least as effective as PPIs in the elimination of Helicobacter Pylori. Assessing the duration of Vonoprazan based triple therapy is of great concern.

Enrollment: 246 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen.

Exclusion criteria

• acute gastrointestinal disease (e.g., acute diarrhea)
• chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
• known renal and/or liver failure
• no known malignancy
• varices bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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246 participants in 2 patient groups, including a placebo group

2 weeks vonoprazan containing triple regimen

Active Comparator group

Description:

For two weeks: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily

Treatment:

Drug: Vonoprazan, Amoxicillin, Levofloxacin

1 week vonoprazan containing triple regimen

Placebo Comparator group

Description:

For One week: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily For the second week: Placebo

Treatment:

Drug: Vonoprazan, Amoxicillin, Levofloxacin