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Lactobacillus reuteri (Gastrus®) was not anymore available in the region
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This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.
Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B.I.D. TMPPI + Lactobacillus-10 | Experimental | pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days |
|
| B.I.D. Bismuth | Active Comparator | pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bismuth Subcitrate Potassium | Drug | Pylera capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | a negative 13C-urea breath test and/or a negative stool antigen test | 30-40 days after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance and side effects evaluation | Patient interview at the end of treatment | 30-40 days |
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Inclusion Criteria:
- Positive for H. pylori infection
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARIA P Dore, MD, PhD | Università degli Studi di Sassari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale | Sassari | SS | 07100 | Italy |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D013752 | Tetracycline |
| D000077402 | Pantoprazole |
| D001729 | Bismuth |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Gastrus | Dietary Supplement | Gastrus 1 tablet |
|
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |