Title
Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori
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
Phase
Phase 4Lead Sponsor
University Hospital, RijekaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Helicobacter Pylori InfectionIntervention/Treatment
bifidobacterium animalis lactobacillus rhamnosus ...Study Participants
804The 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.
One capsule twice a day/14 days
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
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.
Inclusion Criteria: Confirmed H. Pylori infection. 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: Pregnancy or lactation. 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.
