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Completed

NCT Number: NCT02547038

Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

About this study

A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pantoprazole+bismuth+tetra+metro

Drug

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

Other names: pantoprazole 40 mg, bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 250 mg

(panto+amox+clar+metr)+(panto+amox)

Drug

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Other names: pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mg

Primary outcomes

  1. Number of Participants in Which H. Pylori Was Eradicated

    Time frame: sixth week after the end of anti- H. pylori therapy

    Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Comparing the Efficacy and Impact on Gastrointestinal Microbiome of Reverse Hybrid Therapy and Bismuth Quadruple Therapy in Helicobacter Pylori Eradication

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2015
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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