Overview

Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection

Status:
Unknown status
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dallas VA Medical Center
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatments:
Amoxicillin
Clarithromycin
Metronidazole
Omeprazole
Criteria
Inclusion Criteria:

Subject has signed informed consent Subject is an adult older than 18 yrs old and requires
an upper endoscopic evaluation If female and of child bearing potential, subject has a
negative pregnancy test and is not nursing.

Patient has not received prior treatment for H pylori Subject is able to understand and
comply with study procedures

Exclusion Criteria:

Recent use (within 4 weeks) of any of the medications used in the treatment of H
pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute
gastrointestinal bleeding Subject has an allergy to any of the medications used in the
treatment of H pylori Subject has a history of esophageal or gastric carcinoma including
lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding
Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe
biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the
study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is
already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication