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

Helicobacter Pylori Eradication Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02833623
• Other study ID #: 2016SDU-QILU-07
• Status: Recruiting
• Phase: Phase 4
• First received: July 7, 2016
• Last updated: October 12, 2016
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Shandong University
• Contact: Yanqing Li, MD,PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication Rate

Intervention

Behavioral:
• Short-message-based Re-education

• conventional education

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The different rate of adverse events between 2 groups		8 months	No
Other	The different rate of symptom remissions after Hp eradication therapy between 2 groups		8 months	No
Primary	The difference of H. pylori eradication rate between two groups		8 months	No
Secondary	Rate of non-compliance with instructions between 2 groups		8 months	No