Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori Lactobacillus reuteri dyspeptic patients eradication
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

Detailed description:
Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.

Arms:
arm 1: The active group that will receive the standard triple therapy and Lactobacillus reuteri arm 2: The control group that will receive the standard triple therapy and placebo

Interventions: intervention 1: Lactobacillus reuteri intervention 2: Placebo intervention 3: Omeprazole intervention 4: Amoxicillin intervention 5: Clarithromycin
Intervention descriptions: intervention 1: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks. intervention 2: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks. intervention 3: All patients will receive omeprazole 20 mg b.i.d for 2 week intervention 4: amoxicillin 1000 mg b.i.d for 2 weeks intervention 5: clarithromycin 500mg b.i.d for 2 weeks

Protocol document: