High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Bismuth Potassium Citrate

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bismuth Plus Dual Therapy; Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Bismuth Potassium Citrate 600mg bid for 14 days.	Drug: Esomeprazole; Proton pump inhibitor; Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect
ACTIVE_COMPARATOR: Dual Therapy; Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days.	Drug: Esomeprazole; Proton pump inhibitor; Drug: Amoxicillin; Antibiotic for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Hong Lu, M.D, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2018
• Primary Completion (ACTUAL): November 2, 2018
• Study Completion (ACTUAL): November 2, 2018

Study Registration Dates

• First Submitted: January 13, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Respiratory System Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Expectorants; Antacids; Amoxicillin; Esomeprazole; Bismuth; Potassium Citrate
• Other Study ID Numbers: rjkls2017196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No