Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 4

Conditions: Helicobacter Infections

Treatments: Drug: Sequential therapy; Drug: Triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02395458

R-2013-3609-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Sequential therapy

Experimental group

Description:

Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days

Treatment:

Drug: Sequential therapy

Triple therapy

Active Comparator group

Description:

Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days

Treatment:

Drug: Triple therapy