Aleatorization ITT Sample

<i>Saccharomyces</i><i> boulardii </i>CNCM I-745 (Sb Floratil) is a probiotic with demonstrated efficacy in children with acute diarrhea; however, evidence on its use in bloody diarrhea (BD) is lacking; hence, a double blind, placebo-controlled multicenter clinical trial was carried out to assess its efficacy and safety in children with BD aged 0.25 to 5.99 years. Children with BD of 7 days duration or less, with no chronic disease were selected. Ninety-six children from three hospitals in Argentina adhered to the protocol and were enrolled in the study. Patients received either Sb CNCM I-745 (Floratil, Biocódex, France) (500 or 250 mg /day, according to age) or its placebo during seven days. Children were seen at hospital on days 1, 3 and 7, and contacted by telephone calls on day 14. Stool frequency and product intake were registered daily by parents at home. Fifty two and 44 patients received Sb or placebo respectively). Main results . were duration of bloody stools and daily number of stools in each group. Adverse events (were registered as well as results of stool cultures. <br>