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

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Omeprazole; Drug: Clarithromycin; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05342532

STUDY-19-01590

Details and patient eligibility

About

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.

Full description

All patients, at least 18 years of age, with a chief complaint of dyspepsia and documented treatment-naïve HP infection diagnosed on UBT, esophagogastroduodenoscopy (EGD) with HP biopsy, or SAT were recruited for the study. Dyspepsia was defined as persistent or recurrent abdominal pain for at least one month. All subjects who met inclusion criteria were randomly assigned by a computerized system to one of two treatment groups: standard triple therapy (STT) or high-dose dual therapy (HDDT). After patient randomization, all potential side effects were discussed. Education regarding the importance of adherence to complete the full 14 day regimen was provided. Patients were provided an electronic prescription for the respective assigned regimen along with a medication log to self-report drug compliance. The patients were asked to record medication compliance and report any adverse events to research personnel.

After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. During this period, patients were asked to abstain from taking PPI's to avoid false negative eradication testing. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

High Dose Dual Therapy

Active Comparator group

Description:

This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.

Treatment:

Drug: Amoxicillin

Drug: Omeprazole

Standard triple therapy

Active Comparator group

Description:

This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.

Treatment:

Drug: Amoxicillin

Drug: Clarithromycin

Drug: Omeprazole