The comparison between the probiotic supplementation and the placebo on the tolerance and efficacy of quadruple therapy in helicobacter pylori positive patients

This is a randomized double blind placebo controlled trial on 80 h.pylori positive patients diagnosed by histopathology, in Rasht and Anzali, Iran, in one year period in 2011-2012. The inclusion criterion is the presence of h.pylori by histopathology of the biopsy specimen. The exclusion criteria are malignancy; prior h.pylori eradication; GI bleeding; prior gastrectomy; inflammatory bowel disease; immunodeficiency; valvular heart disease; any probiotic supplementation consumption in treatment period. The patients are divided in the placebo and the treatment group by random allocation. The treatment group receives quadruple therapy of Clarithromycin 500 mg bid, Amoxicillin 1g bid, Bismuth 525mg qid, Omeprazole 20 mg bid and 2 probiotic capsules(Protexin BALANCE) daily for 14 days. The placebo group also receives the same quadruple therapy and 2 Placebo capsules daily for 14 days. Meanwhile, receiving of the placebo and the probiotic capsule in the placebo and the treatment group begins 3 days before the starting of 14 days therapy, respectively. The assessment of symptoms improvement and the drug adverse effects is done by Glasgow dyspepsia questionnaire and modified version of the questionnaire by de Boer et al. The h.pylori eradication is confirmed by urea breath test(UBT) 4 weeks after the finishing of treatment period.

Dean of Medical School, Guilan University of Medical Sciences