University Hospital Rijeka
Rijeka, 51000, Croatia
NCT Number: NCT01969331
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
Looking for future studies?
Notify Me16 year and older
All sexes
Interventional
Phase 4
Rijeka, 51000, Croatia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One capsule twice a day/14 days
Other names: Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12®
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
Time frame: 40-44 days
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:
Time frame: 40-44 days
Subjects will receive therapy considered to be a "golden standard" for this indication (triple therapy eradication protocol). Subjects receiving Placebo will be receiving standard triple therapy as well.
Goran Hauser
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05742568
Digestive System Diseases, Digestive System Neoplasms
Xi'an, Shaanxi, China
View Trial DetailsNCT06576882
Adolescents, Digestive System Diseases
Alexandria, Egypt
View Trial DetailsNCT04678492
Digestive System Diseases, Digestive System Neoplasms
Xi'an, Shaanxi, China
View Trial DetailsNCT00132171
Chronic Active Gastritis, Digestive System Diseases
Rome, Italy
View Trial Details