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Completed

NCT Number: NCT03413020

Tailored Therapy for Helicobacter Pylori Rescue Treatment

With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–75 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 scarred peptic ulcer disease
  • Previous failures of H. pylori eradication therapy and need rescue therapy
  • Ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed H. pylori infection

Exclusion criteria

  • Less than 18 years old
  • 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

Bismuth Potassium Citrate

Drug

gastric mucosal protective drug with anti-H. pylori effect

Amoxicillin

Drug

antibiotic for H. pylori eradication

Clarithromycin

Drug

antibiotic for H. pylori eradication

Metronidazole

Drug

antibiotic for H. pylori eradication

Levofloxacin

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.

Other outcomes

  1. Medical cost per patient of tailored therapy

    Time frame: Two months after completion of therapy

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Efficacy of Tailored for Helicobacter Pylori Rescue Treatment Based on Antimicrobial-susceptibility Testing

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Aug 7, 2018

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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