Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Bismuth quadruple therapy; Drug: Hybrid therapy

• Registration Number: NCT02541864
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.

Detailed Description

For this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at a 1:1 ratio. Our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-08-31
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Results First Submitted: 2017-07-12
• Results First Submitted QC: 2017-07-12
• Results First Posted: 2017-08-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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
Bismuth quadruple therapy	Bismuth quadruple therapy	pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days
Hybrid therapy	Hybrid therapy	(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)

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	Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.