Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication

October 12, 2016 updated by: Yanqing Li, Shandong University
Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatients aged 18-70 years
  • confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
  • an intention of H. pylori eradication treatment and have written inform consent
  • ability to read short messages on the mobile phone

Exclusion Criteria:

  • advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
  • allergy to any of the drugs used in this study
  • previous Helicobacter Pylori eradication treatment
  • pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
  • taking antibiotics or PPIs or bismuth salts within four weeks
  • previous gastrointestinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short-message-based Re-education group

Patients receive oral and written education before H. pylori eradication therapy at first, then they receive short message re-education twice per day during therapy.

Both the content of the oral and written education and the short message re-education are same.
Behavioral: Short-message-based Re-education
Active Comparator: conventional education group
Patients only receive oral and written education before H. pylori eradication therapy.
Behavioral: conventional education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference of H. pylori eradication rate between two groups
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of non-compliance with instructions between 2 groups
Time Frame: 8 months
8 months

Other Outcome Measures

Outcome Measure
Time Frame
The different rate of adverse events between 2 groups
Time Frame: 8 months
8 months
The different rate of symptom remissions after Hp eradication therapy between 2 groups
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016SDU-QILU-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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