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

Completed · Phase 4

Conditions studied: Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID

NCT05342532

Run by

Icahn School of Medicine at Mount Sinai

People needed

112

Starts

2019-06-12

Expected to finish

2022-01-01

Last updated by the study team

2023-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mount Sinai Union Square Division of Digestive Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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