An Interventional, Prospective, Multi-center, Double-blind, Placebo Controlled Postmarketing Study to Evaluate Efficacy and Safety of Normia® Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori
Sponsor study identifier
interventional
804
1 country
1
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 2010
Actual (reported)December 2010
Actual (reported)October 9, 2013
Actual (reported)October 25, 2013
Actual (reported)Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen
Duration of participation in the study will depend on the duration of therapy prescribed by the attending physician. The exact type of the basic (triple) therapy prescribed to each subject is at the discretion of the physician. Assuming standard therapy regimes for this indication, the shortest possible participation in the study will be as follows: * 7 days of initial triple therapy, followed by * 21 days of PPI therapy only, followed by * 14 days +/- 2 days to the follow up visit. Therefore, study participation will take between 40 and 44 days.
40-44 days
Reducing the number of adverse events for H. pylori eradication triple therapy using Normia® probiotic as a supportive therapy
40-44 days
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171) Placebo as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy. Two weeks after the end of PPI therapy subjects are seen at the follow up visit.
Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12® Normia® probiotic as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy. One capsule twice per day/14 days Two weeks after the end of PPI therapy subjects are seen at the follow up visit.
One capsule twice a day/14 days
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
University Hospital Rijeka
Rijeka, Rijeka, 51000, Croatia
Goran Hauser, MD,PhD
UH Rijeka
804 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2013
First Posted
October 25, 2013
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
August 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
October 25, 2013
Record last verified: 2013-10
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Source: ClinicalTrials.gov.
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