RESUMEN
OBJECTIVE: The aim of this study is to analyze the effect, safety and tolerability of a specific probiotic combination of Lactobacillus and Bifidobacterium strains (Pearls IC©) on antibiotic associated diarrhea due to amoxicillin-clavulanic acid treatment. METHODS: Pilot, unicentric, randomized, double-blind, parallel group, placebo-controlled study (probiotic vs. placebo for 30 days). Target population: Adult patients, both sexes treated with amoxicillin-clavulanic acid (850mg / 125mg every 8h /orally) for 7 days who attended the Emergency Department (Dexeus Hospital, Barcelona) between January and April of 2018 with prior signed informed consent with a follow up at 30 days. Variables: The differences between day 0 and day 30 of the number of daily stools and duration of diarrhea were evaluated; Stool consistency according to Bristol Stool Form, Quality of intestinal life. Subjective evaluation and evaluation of adverse effects of the product through a specifically designed questionnaire. RESULTS: Thirty-six subjects were included (18 per group) 25 females and 11 males, average age of 38.5 years (range 19-65 years). Pearls IC© delayed between 4 and 5 days the appearance of the diarrheic episode vs. placebo (p <0.001). The results of the quality of life assessment showed an improvement at the end of the 30 days period but without difference vs placebo. The results of the subjective assessment were in favor of the probiotic with higher rate of like responses than placebo. CONCLUSIONS: Pearls IC© demonstrated its beneficial effect on antibiotic associated diarrhea by delaying the onset of diarrhea and showed a tendency to decrease the number of daily stools vs. placebo.