Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens
Phase 4
Completed
- Conditions
- Helicobacter Infections
- Interventions
- Drug: Sequential therapyDrug: Triple therapy
- Registration Number
- NCT02395458
- Lead Sponsor
- Coordinación de Investigación en Salud, Mexico
- Brief Summary
Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.
- Detailed Description
In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
Inclusion Criteria
- Helicobacter pylori infection in biopsy
- Eradication required
Exclusion Criteria
- Antibiotic received two weeks prior
- Previous treatment for H pylori infection
- Allergy to any of the treatment drugs
- Smoking > 5 cigarettes daily.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequential therapy Sequential therapy Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days Triple therapy Triple therapy Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days
- Primary Outcome Measures
Name Time Method Eradication 6 to 8 week after treatment Helicobacter pylori in gastric biopsy
- Secondary Outcome Measures
Name Time Method Side effects two weeks after beginning of treatment Nausea, vomiting, stomach ache