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NCT Number: NCT02935010

Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, China

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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
  • Ability and willingness to participate in the study and to sign and give informed consent
  • confirmed H. pylori infection

Exclusion criteria

  • Previous H. pylori eradication therapy
  • Less than 18 years old
  • With history of H. pylori infection treatment
  • 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

    During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. 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). The side effect score recorded was based on the most severe event.

  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 or empiric therapy

    Time frame: two months after completion of therapy

  2. Ratio of medical cost to H. pylori eradication rate of each therapy

    Time frame: two months after completion of therapy

  3. Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric 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 Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Aug 15, 2018

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

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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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