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Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori

NCT01969331 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2013-10-25

No results posted yet for this study

Summary

The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach.

The primary objective in the study is determination of efficacy of Normia® probiotic as a supportive therapy in achieving a higher percentage of eradication of H. Pylori.

The secondary objectives are to assess:

* Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of side-effects and better compliance to the eradication therapy
* Safety and efficacy of Normia® probiotic in different demographic subgroups

Conditions

  • Helicobacter Pylori Infection

Interventions

DIETARY_SUPPLEMENT

Normia

One capsule twice a day/14 days

DIETARY_SUPPLEMENT

Placebo

maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)

Sponsors & Collaborators

  • Jadran Galenski laboratorij d.d.Rijeka

    collaborator UNKNOWN

  • Goran Hauser

    lead OTHER

Principal Investigators

  • Goran Hauser, MD,PhD · UH Rijeka

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-08-31
Completion
2010-12-31

Countries

  • Croatia

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 NCT01969331 on ClinicalTrials.gov