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Telephone-Based Re-education for Hp Eradication

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ClinicalTrials.gov Identifier: NCT03193450
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
He Shuixiang, First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Behavioral: telephone-based re-education Behavioral: First education at the clinic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Telephone-Based Re-Education of Drug Administration for Helicobacter Pylori Eradication: a Multi-Center Randomized, Controlled Study
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Arm Intervention/treatment
Experimental: Re-education group
Patients in this arm 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.
Behavioral: telephone-based re-education
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.

Behavioral: First education at the clinic
Patients will receive an instruction card about the drug administration at the clinic by doctors.

Active Comparator: Non re-education group
Patients in this arm only received an instruction card about the drug administration at the clinic by doctors but no re-education by telephone during treatment
Behavioral: First education at the clinic
Patients will receive an instruction card about the drug administration at the clinic by doctors.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Prior informed consent
  2. 18-70 years of age
  3. 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
  4. Ability to swallow oral medications
  5. No contraindication for the drugs used for Hp eradication
  6. 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:

  1. Pregnant or breast-feeding subjects
  2. Previous failed treatment of Hp eradication
  3. 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
  4. 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.)
  5. Previous upper gastrointestinal surgery
  6. Inability to express complaint (e.g. mental disorder, psychoneurosis, unable to cooperation, etc.)
  7. Active clinically serious infections, except for Hepatitis B virus and hepatitis C virus infection
  8. Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193450


Locations
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China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Shuixiang He, MD, PhD First Affiliated Hospital Xi'an Jiaotong University

Publications:
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Responsible Party: He Shuixiang, Director of the Department of Gastroenterology, First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03193450     History of Changes
Other Study ID Numbers: XAJTU-DG001
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by He Shuixiang, First Affiliated Hospital Xi'an Jiaotong University:
helicobactor pylori

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections