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

Study Overview
=================
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.

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

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Bismuth Potassium Citrate
* Drug: Clarithromycin
* Drug: Metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triple regimen group<br>Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days | Drug: Esomeprazole<br>* Given 30 min before morning and evening meals<br>Drug: Clarithromycin<br>* Given 30 min after morning and evening meals<br>Drug: Metronidazole<br>* Given 30 min after meals or at bedtime<br>|
| Experimental: Low metronidazole group<br>Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days | Drug: Esomeprazole<br>* Given 30 min before morning and evening meals<br>Drug: Bismuth Potassium Citrate<br>* Given 30 min before morning and evening meals<br>Drug: Clarithromycin<br>* Given 30 min after morning and evening meals<br>Drug: Metronidazole<br>* Given 30 min after meals or at bedtime<br>|
| Experimental: High metronidazole group<br>Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days | Drug: Esomeprazole<br>* Given 30 min before morning and evening meals<br>Drug: Bismuth Potassium Citrate<br>* Given 30 min before morning and evening meals<br>Drug: Clarithromycin<br>* Given 30 min after morning and evening meals<br>Drug: Metronidazole<br>* Given 30 min after meals or at bedtime<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate |  | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects |  | within 7 days after completion of therapy | 
| Compliance rate |  | within 7 days after completion of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, Clarithromycin, Amoxicillin, Metronidazole, Eradication