Clinical trial NCT01969331: Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Gastritis
Helicobacter pylori
Lead sponsor: University Hospital Rijeka
Sponsor class: OTHER
Collaborators: name: Jadran Galenski laboratorij d.d.Rijeka
First posted: 2013-10-25
Enrollment: 804
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen
timeFrame: 40-44 days
Secondary outcomes:
measure: Reducing the number of adverse events for H. pylori eradication triple therapy using Normia® probiotic as a supportive therapy
timeFrame: 40-44 days
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: University Hospital Rijeka
Study officials:
affiliation: UH Rijeka
name: Goran Hauser, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: