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

Not Applicable

• Conditions: Helicobacter Infection
• Interventions: Drug: Standard Triple Therapy; Drug: Sequential Therapy

• Registration Number: NCT01723059
• Lead Sponsor: Dallas VA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-11
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-05
• Last Update Submitted: 2012-11-05
• Study First Posted: 2012-11-07
• Last Update Posted: 2012-11-07
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard triple therapy	Standard Triple Therapy	Gold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days.
Sequential Therapy	Sequential Therapy	Amoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days.

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication	4 weeks after completion of treatment

Trial Locations

Locations (1)

Dallas VAMC; 🇺🇸 Dallas, Texas, United States