Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969331
• Other study ID #: JGL/02/09
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2013
• Last updated: October 21, 2013
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2013
• Source: University Hospital Rijeka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Jadran Galenski Laboratorij pharmacovigilancy
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Dietary Supplement:
• Normia
One capsule twice a day/14 days
• Placebo
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)

Locations

Country	Name	City	State
Croatia	University Hospital Rijeka	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
Goran Hauser	Jadran Galenski laboratorij d.d.Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes