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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01969331
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Collaborator:
Jadran Galenski laboratorij d.d.Rijeka
Information provided by (Responsible Party):
Goran Hauser, University Hospital Rijeka

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

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Dietary Supplement: Normia Dietary Supplement: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : December 2010

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 Name: Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12®




Primary Outcome Measures :
  1. Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen [ 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:

    • 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.


Secondary Outcome Measures :
  1. Reducing the number of adverse events for H. pylori eradication triple therapy using Normia® probiotic as a supportive therapy [ 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969331


Locations
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Croatia
University Hospital Rijeka
Rijeka, Croatia, 51000
Sponsors and Collaborators
Goran Hauser
Jadran Galenski laboratorij d.d.Rijeka
Investigators
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Principal Investigator: Goran Hauser, MD,PhD UH Rijeka

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Responsible Party: Goran Hauser, Goran Hauser MD, PhD, University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT01969331     History of Changes
Other Study ID Numbers: JGL/02/09
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by Goran Hauser, University Hospital Rijeka:
Gastritis
Helicobacter pylori

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Titanium dioxide
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents