High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05342532
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose Dual Therapy Amoxicillin This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. High Dose Dual Therapy Omeprazole This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. Standard triple therapy Amoxicillin This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. Standard triple therapy Omeprazole This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. Standard triple therapy Clarithromycin This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
- Primary Outcome Measures
Name Time Method Number of Participant With Eradication of Disease end of study at 6 weeks The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.
- Secondary Outcome Measures
Name Time Method Number of Participants Completing at Least 90% of All Prescribed Medications end of study at 6 weeks Patients were provided a medication log to self-report drug compliance. After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. 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).
Number of Participants With Protocol Specific Adverse Events end of study at 6 weeks Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia
Trial Locations
- Locations (1)
Mount Sinai Union Square Division of Digestive Diseases
🇺🇸New York, New York, United States