High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment：a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405584
• Other study ID #: rjkls2017196
• Status: Completed
• Phase: Phase 4
• Start date: January 3, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: January 2018
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants with non-ulcer functional dyspepsia or peptic ulcer disease

• Ability and willingness to participate in the study and to sign and give informed consent

• Confirmed H. pylori infection

Exclusion Criteria:

• Less than 18 years old

• With previous gastric surgery

• Major systemic diseases

• Pregnancy or lactation

• Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• Amoxicillin
Antibiotic for H. pylori eradication
• Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).	Six weeks after completion of therapy
Secondary	Rate of adverse effects	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).	Within 7 days after completion of therapy.
Secondary	Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication.	Within 7 days after completion of therapy.