Telephone-Based Re-education for Hp Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193450
• Other study ID #: XAJTU-DG001
• Status: Completed
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: May 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (3)

Malfertheiner P, Sipponen P, Naumann M, Moayyedi P, Mégraud F, Xiao SD, Sugano K, Nyrén O; Lejondal H. pylori-Gastric Cancer Task Force. Helicobacter pylori eradication has the potential to prevent gastric cancer: a state-of-the-art critique. Am J Gastroenterol. 2005 Sep;100(9):2100-15. Review. — View Citation

McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. Review. — View Citation

Svedlund J, Sjödin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hp eradication rate	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	4-6 weeks after the end of drug administration
Secondary	Symptoms relief rate	The symptoms were recorded according to Gastrointestinal Symptom Rating Scale.	4-6 weeks after the end of drug administration
Secondary	Adverse events	The terms and grade of adverse events will be presented according to the Common Terminology Criteria for Adverse Events (CTCAE: version 4.0)	4-6 weeks after the end of drug administration