Probiotics have been used in humans for almost a century and are widely recommended because they play an important role in gastrointestinal physiological and pathophysiological processes. The aim of this study was to evaluate the effi- cacy and safety of a probiotic mixture in healthy volunteers with evacuation disorders. We undertook a prospective study with historical control. We used the number of evacuations, effort and stool consistency 10 days before, 10 days during and 10 days after treatment with the probiotic as primary outcome measures. Eligible par-ticipants comprised 25 patients with an average age of 25.12 years (range: 18 - 55) who suffered from evacuation disorders. BIO L6 is a func- tional food consisting of a probiotic preparation that contains 1 mg (108 CFUs) of lyophilized strains of Lactic Acid Bacteria resuspended in 250 mL of drinking water. The probiotic preparation was prescribed daily for two weeks, five days a week. A significant increase in the number of evacuations was observed in 23 patients during BIO L6 consump- tion and continued in 20 after consumption. The degree of effort spent defecating decreased in 17 patients during treat- ment and in 7 after treatment. A significant improvement (P < 0.001) in stool consistency was also observed in all pa- tients receiving BIO L6. Fourteen patients had at least one adverse event (AE) for one or two days during treatment; most treatment-related AEs were considered minor or mild in terms of severity and were consistent with AEs reported for probiotic consumption. The results of this study suggest that the use of probiotic mixture BIO L6 is effective, safe and tolerable and provides beneficial effects for subjects with evacuations disorders.
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