Helicobacter Pylori Infection Clinical Trial
Official title:
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
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
Gastroenterologists and general practitioners have increasingly more possibilities of
prescribing probiotic preparations as the only or (more often) adjuvant therapy in certain
indications. A significant step forward was made in the current report of the European
Helicobacter Study Group ,which states that "Certain probiotics and prebiotics show
promising results as an adjuvant treatment in reducing side effects". At this
stage,probiotics are classified as Grade D recommendation. That is precisely why the
investigators believe that clinical studies are necessary in order for such effects to be
objectively proven in a clinical setting.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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