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Completed

NCT Number: NCT04024527

High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with non-ulcer functional dyspepsia or peptic ulcer disease
  • Ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed H. pylori infection and with previous treatment failure

Exclusion criteria

  • Less than 18 years old or older than 80 years
  • With previous gastric surgery
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs
  • Administration of antibiotics, bismuth,antisecretory drugs in 8 weeks prior to inclusion

Treatment and study plan

Esomeprazole

Drug

Proton pump inhibitor

Amoxicillin

Drug

Antibiotic for H. pylori eradication

Metronidazole

Drug

Antibiotic for H. pylori eradication

Primary outcomes

  1. Helicobacter pylori eradication rate

    Time frame: Six weeks after completion of therapy

    Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value)

Secondary outcomes

  1. Rate of adverse effects

    Time frame: Within 7 days after completion of therapy

    The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)

  2. Compliance rate

    Time frame: Within 7 days after completion of therapy

    Compliance was defined as poor when they had taken less than 80% of the total medication

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Efficacy of High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori Rescue Treatment: A Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2019
Registry last updated
Sep 28, 2021

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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