Helicobacter Infection
Conditions
Brief 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.
Interventions
for 10 days
total 10 days
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Dallas VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori eradication | 4 weeks after completion of treatment |
Countries
United States
Contacts
Primary ContactByron Cryer, MD
Backup ContactElizabeth Coss, MD
Outcome results
None listed