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| Name | Class |
|---|---|
| Jadran Galenski laboratorij d.d.Rijeka | UNKNOWN |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
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| Normia | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normia | Dietary Supplement | One capsule twice a day/14 days |
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| 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:
| 40-44 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goran Hauser, MD,PhD | UH Rijeka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Rijeka | Rijeka | Rijeka | 51000 | Croatia |
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| Placebo | Dietary Supplement | maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171) |
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