Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Reverse hybrid therapy; Drug: Standard triple therapy

• Registration Number: NCT02359435
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection with less cost than standard triple therapy. Whether reverse hybrid therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in first-line treatment.

Detailed Description

For this multicentre, single-blind, and randomized-controlled trial (REHYTRI study), the investigator recruited patients with H pylori infection. Using a computer-generated randomization sequence, the investigator randomly allocated patients to either 12-day reverse hybrid therapy (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days; with all drugs given twice daily) or a 12-day standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg, amoxicillin 1 g for 12 days; with all drugs given twice daily) at a 1:1 ratio. Our primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2015-01-25
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Results First Submitted: 2016-01-11
• Results First Submitted QC: 2016-01-11
• Results First Posted: 2016-02-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria

• previous H pylori-eradication therapy
• ingestion of antibiotics or bismuth within the prior 4 weeks
• patients with allergic history to the medications used
• patients with previous gastric surgery
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reverse hybrid therapy	Reverse hybrid therapy	pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
Standard triple therapy	Standard triple therapy	pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which H. Pylori Was Eradicated	at the 6th week after the end of anti- H. pylori therapy	Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan