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

Goran Hauser

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Dietary Supplement: Normia; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01969331

JGL/02/09

Details and patient eligibility

About

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

Full 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.

Enrollment: 804 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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804 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Normia

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Normia