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Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii

NCT03997279 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-06-25

No results posted yet for this study

Summary

This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Saccharomyces boulardii

Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Saccharomyces boulardi 500 mg 1x1, for 3 week

DRUG

Placebo

Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Placebo 1x1, for 3 week

Sponsors & Collaborators

  • Clinical Centre of Serbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-06-30
Completion
2020-06-30

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Drugs

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 NCT03997279 on ClinicalTrials.gov