drugset / Trial / NCT03146325

Helicobacter Pylori and Body Iron in Adults

NCT03146325

RandomizedParallel-groupDouble-blindPrevention

Summary

This study is an etiologic trial to test the hypothesis that predicts that Helicobacter pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body iron. The study will assign and aims to complete the follow-up of 240 subjects half of them assigned to a highly effective FDA approved 14-day course of a 3-1 capsule containing bismuth subcitrate, metronidazole and tetracycline plus omeprazole which is now OTC. We have tested the effectiveness of this therapy in the study population and it seems to yield almost 100% eradication on PP analysis. We need the best possible, near 100% eradication rate, which we have already obtained in a pilot, to make comparisons on ITT basis and safely conclude that H pylori leads to a deficit of body iron.

Timeline

Start
2012-11
Primary completion
2016-06
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Metronidazole Small molecule 375 mg
Subject Omeprazole Other / unclassified 20 mg
Subject Tetracycline Unknown 375 mg
Subject bismuth subcitrate Unknown 420 mg