The Role of Probiotics in the Eradication of Helicobacter Pylori

Study Overview
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Brief Summary
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All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well. The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).

Detailed Description
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Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well. The probiotic contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule). Patients will report in a specific questionnare the presence or absence of symptoms suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal pain, diarrhoea, regurgitation, vomiting). All patints will be subjected to urea breath test one month after the completion of treatment in order to verify HP eradication.

Official Title
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The Role of Probiotics in the Eradication of Helicobacter Pylori

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Caps Lactolevure
* Drug: Caps Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established Helicobacter Pylori Infection Exclusion Criteria: Pregnancy Lactate Previous eradication therapy for HP. Course of antibiotics and/or probiotics one month prior to stydy entry Course of PPI's, H2- antagonst and antacids two weeks prior to study entry Known allergy to antibiotics that will be used in study Coronary disease, heart failure,malignancy,thyroid disease, pulmonary disease or other serious disease as per medical judgment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactolevure<br>Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Probiotics | Drug: Caps Lactolevure<br>* One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.<br>* Other names: Probiotics;|
| Placebo Comparator: Placebo<br>Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Placebo | Drug: Caps Placebo<br>* Caps Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of antibiotic side effects | Primary prevention of Abx side effects as assessed by a questionnaire including all possible side effects (i.e. vomiting, diarrhea, flatulence etc) on a ten point Likert scale. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter Pylori, Probiotics, Eradication treatment of H.Pylori, Antibiotics, Proton pump inhibitors, Saccharomyces boulardii, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus plantarum