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Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

NCT01593592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-08-17

Study results available
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Summary

Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

Conditions

  • Helicobacter Pylori Infection

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.

DIETARY_SUPPLEMENT

Placebo

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.

DRUG

Omeprazole

All patients will receive omeprazole 20 mg b.i.d for 2 week

DRUG

Amoxicillin

amoxicillin 1000 mg b.i.d for 2 weeks

DRUG

Clarithromycin

clarithromycin 500mg b.i.d for 2 weeks

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-01-31

Countries

  • Egypt

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 NCT01593592 on ClinicalTrials.gov