Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

Phase 4

Completed

• Conditions: Helicobacter Infections
• Interventions: Drug: Sequential therapy; Drug: 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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-17
• Study First Posted: 2015-03-23
• Last Update Posted: 2015-03-23

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