High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

• Status: Completed
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high dose dual therapy vs standard triple therapy in a diverse, urban New York City population.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Amoxicillin; Clarithromycin; Omeprazole

Criteria

Inclusion Criteria:

• Age 18 or older

• Treatment-naïve

• Clinical diagnosis of helicobacter pylori infection based on urea breath test, endoscopy or stool antigen test

• Subject willing to participate and able to provide informed consent.

Exclusion Criteria:

• Prior helicobacter pylori treatment failure

• Antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis

• Pregnancy or breastfeeding

• Penicillin allergy

• History of active or non-gastric malignancy

• Severe illness requiring hospitalization during treatment period

• Starting additional antibiotic while on treatment