Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732249
• Other study ID #: rjkls2016068
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2016
• Est. completion date: September 30, 2017

Study information

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

Clinical Trial Summary

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

• confirmed H. pylori infection

Exclusion Criteria:

• Previous H. pylori eradication therapy

• Less than 18 years old

• With history of H. pylori infection treatment

• 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
Given 30 min before morning and evening meals
• Bismuth Potassium Citrate
Given 30 min before morning and evening meals
• Clarithromycin
Given 30 min after morning and evening meals
• Metronidazole
Given 30 min after meals or at bedtime

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
Secondary	Rate of adverse effects		within 7 days after completion of therapy
Secondary	Compliance rate		within 7 days after completion of therapy