Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori
NCT ID: NCT01969331
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
804 participants
INTERVENTIONAL
2008-12-31
2010-12-31
Brief Summary
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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
Detailed Description
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The investigators decided to conduct a clinical trial based on a clearly defined and sufficiently frequent indication,with a preparation of known probiotic composition that is easily available on the market, and in a real setting where such approach is bound to show both advantages and disadvantages.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
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.
Placebo
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
Normia
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.
Normia
One capsule twice a day/14 days
Interventions
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Normia
One capsule twice a day/14 days
Placebo
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Otherwise healthy subjects taking H. pylori eradication therapy.
* Age above 16 years.
* Male and female subjects.
* Subject who provided written informed consent prior to undergoing any study procedure.
Exclusion Criteria
* Severe diseases such as malignant diseases, severe renal/liver impairment, HIV infection etc.
* Chronic diseases such as diabetes mellitus, hypertension, epilepsy or atherosclerosis which are under treatment and well regulated are not an exclusion criterion.
* Subject who is not mentally capable of adhering to the protocol.
* Drug addiction or alcoholism.
* Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
* Subjects participating in any other clinical trial.
16 Years
ALL
No
Sponsors
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Jadran Galenski laboratorij d.d.Rijeka
UNKNOWN
Goran Hauser
OTHER
Responsible Party
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Goran Hauser
Goran Hauser MD, PhD
Principal Investigators
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Goran Hauser, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
UH Rijeka
Locations
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University Hospital Rijeka
Rijeka, Rijeka, Croatia
Countries
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Other Identifiers
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JGL/02/09
Identifier Type: -
Identifier Source: org_study_id