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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02732249

Enrollment

Registered

2016-04-08

Start date

2016-04-01

Completion date

2017-09-30

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori, Clarithromycin, Amoxicillin, Metronidazole, Eradication

Brief 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.

Interventions

DRUGEsomeprazole

Given 30 min before morning and evening meals

DRUGBismuth Potassium Citrate

Given 30 min before morning and evening meals

DRUGClarithromycin

Given 30 min after morning and evening meals

DRUGMetronidazole

Given 30 min after meals or at bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Helicobacter pylori eradication rate	Six weeks after completion of therapy

Secondary

Measure	Time frame
Rate of adverse effects	within 7 days after completion of therapy
Compliance rate	within 7 days after completion of therapy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026