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

Helicobacter Pylori Infection Clinical Trial

Official title:

High-Dose Dual Therapy vs Standard Triple Therapy for Treatment-Naïve H. Pylori: A Prospective Randomized Control Trial in a Diverse Urban New York City Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05342532
• Other study ID #: STUDY-19-01590
• Status: Completed
• Phase: Phase 4
• Start date: June 12, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: January 5, 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Amoxicillin
1 g
• Omeprazole
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
• Clarithromycin
500 mg twice daily

Locations

Country	Name	City	State
United States	Mount Sinai Union Square Division of Digestive Diseases	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participant With Eradication of Disease	The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.	end of study at 6 weeks
Secondary	Number of Participants With Protocol Specific Adverse Events	Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia	end of study at 6 weeks
Secondary	Number of Participants Completing at Least 90% of All Prescribed Medications	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).	end of study at 6 weeks