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Bacillus clausii therapy to reduce side-effects of anti-Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial.

Study Design

Type
Randomized Controlled Trial (RCT)
Population
120 H. pylori-positive patients
Methods
Randomized, placebo-controlled, standard 7 days triple therapy with rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxicillin 1 g b.d. and B. clausii t.d.s. (each preparation containing 2 x 10^9 spores) for 14 days or placebo t.d.s. for 14 days
Duration
14 days
Funding
Unclear
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Background

Helicobacter pylori eradication fails in about 10% of patients, particularly because of the occurrence of resistance to antibiotics and side-effects. During anti-H. pylori therapy, probiotics have been successfully used to reduce the incidence of side-effects.

Aim

To evaluate the effect of Bacillus clausii, a probiotic, on incidence (primary variable) and severity of antibiotic-associated side-effects during anti-H. pylori therapy.

Methods

One hundred and twenty H. pylori-positive patients were randomly screened to receive: (i) a standard 7 days triple therapy with rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxicillin 1 g b.d. and B. clausii t.d.s. (each preparation containing 2 x 10(9) spores) for 14 days starting from the first day of treatment. (ii) The same 7 days triple therapy and placebo t.d.s. for 14 days starting from the first day of treatment. Side-effects were assessed using a validated questionnaire and were recorded for 4 weeks from the start of therapy.

Results

The incidences of nausea, diarrhoea and epigastric pain in patients treated with B. clausii were significantly lower than in placebo group, in both PP and ITT analysis. Equally, intensity of nausea and diarrhoea in patients treated with B. clausii was significantly lower than in placebo group. There were no differences in adherence to treatment and H. pylori eradication rates between groups. Conclusion : In symptom-free, H. pylori-positive subjects B. clausii bacteriotherapy reduces the incidence of the most common side-effects related to anti-H. pylori antibiotic therapy compared with placebo.

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