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Helicobacter Pylori and Body Iron in Adults

NCT03146325 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-05-09

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE

A 14-day quadruple Hp eradication therapy consisting of: omeprazole (20 mg twice daily) plus 3 capsules q.i.d., each containing 420 mg of bismuth subcitrate potassium, 375 mg of metronidazole and 375 mg of tetracycline hydrochloride, for 14 days

DRUG

MATCHING PLACEBO

TO BE PREPARED BY LICENSED COMPOUNDING PHARMACY

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-06-30
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03146325 on ClinicalTrials.gov