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Completed

NCT Number: NCT02646332

Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy

Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains 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 concomitant therapy remains 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

(dexlan+amox+clar+metr)+(dexlan+amox)

Drug

a 7-day quadruple regimen with dexlansoprazole MR 60 mg once 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 dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily

Other names: dexlansoprazole MR 60 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 250 mg

dexlan+clarith+amox+metro

Drug

dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days

Other names: dexlansoprazole MR 60 mg, clarithromycin 500 mg, amoxicillin 1 g, metronidazole 250 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

    To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Comparing the Efficacy and Impact on Gastrointestinal Microbiota of Reverse Hybrid Therapy and Concomitant Therapy in Helicobacter Pylori Eradication

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2016
Registry last updated
Nov 24, 2020

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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