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Completed

NCT Number: NCT03193450

Telephone-Based Re-education for Hp Eradication

It was suggested that the patient compliance plans an important role in the Hp eradication. However, data on whether re-education could improve the eradication rate are lacking. We consider that re-education on patients by telephone during the process of drug administration could increase the eradication rate in Hp infected patients.

We hypothesized that telephone re-education during the whole process of drug administration would improve the compliance of patients and ultimately increase the Hp eradication rate.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prior informed consent
  • 18-70 years of age
  • Hp infected patients diagnosed by 13C urea breath test, including digestive ulcer, gastritis with dyspepsia symptoms, family history of gastric cancer, planning to use long-term non-steroidal anti-inflammatory drugs (NSAIDs), or personal request
  • Ability to swallow oral medications
  • No contraindication for the drugs used for Hp eradication
  • Both men and women enrolled in this trial must use adequate barrier birth control during the course of the trial and 4 weeks after the completion of trial

Exclusion criteria

  • Pregnant or breast-feeding subjects
  • Previous failed treatment of Hp eradication
  • Previous treatment with bismuth salts or antibiotics within 1 month before study enrollment, and treatment with proton pump inhibitor or H2 receptor antagonist within 2 weeks before study enrollment
  • Any disease that could jeopardize the safety of subject and their compliance in the study (e.g. serious liver disease, heart disease, kidney disease, malignant tumor or alcoholism, etc.)
  • Previous upper gastrointestinal surgery
  • Inability to express complaint (e.g. mental disorder, psychoneurosis, unable to cooperation, etc.)
  • Active clinically serious infections, except for Hepatitis B virus and hepatitis C virus infection
  • Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug

Treatment and study plan

telephone-based re-education

Behavioral

Patients will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.

First education at the clinic

Behavioral

Patients will receive an instruction card about the drug administration at the clinic by doctors.

Primary outcomes

  1. Hp eradication rate

    Time frame: 4-6 weeks after the end of drug administration

    Eradication rate is the proportion of patients with eradicated-Hp. Hp infection was considered eradicated when negative results were obtained by 13carbon urea breath test at 4-6 weeks after the end of drug administration

Secondary outcomes

  1. Symptoms relief rate

    Time frame: 4-6 weeks after the end of drug administration

    The symptoms were recorded according to Gastrointestinal Symptom Rating Scale.

  2. Adverse events

    Time frame: 4-6 weeks after the end of drug administration

    The terms and grade of adverse events will be presented according to the Common Terminology Criteria for Adverse Events (CTCAE: version 4.0)

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Telephone-Based Re-Education of Drug Administration for Helicobacter Pylori Eradication: a Multi-Center Randomized, Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2017
Registry last updated
May 30, 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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