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

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

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Normia

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.

• Study Type: Interventional
• Enrollment (Actual): 804
• Phase: Phase 4

Contacts and Locations

Study Locations

• Croatia
  • Rijeka, Croatia, 51000
    • University Hospital Rijeka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: Placebo; maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
Active Comparator: 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.	Dietary supplement: Normia; One capsule twice a day/14 days; Other Names: Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen	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: 7 days of initial triple therapy, followed by; 21 days of PPI therapy only, followed by; 14 days +/- 2 days to the follow up visit. Therefore, study participation will take between 40 and 44 days.	40-44 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reducing the number of adverse events for H. pylori eradication triple therapy using Normia® probiotic as a supportive therapy	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.	40-44 days

Collaborators and Investigators

• Sponsor: Goran Hauser
• Collaborators: Jadran Galenski laboratorij d.d.Rijeka
• Investigators: Principal Investigator: Goran Hauser, MD,PhD, UH Rijeka

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 21, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Gastritis
• Other Study ID Numbers: JGL/02/09