Trial Sb 192 - SUH, Biocodex Data base 10-7-2025.xlsx

Title of the study : Effect of Saccharomyces boulardii CNCM I-745 on the course of bloody diarrhea in children: a double blind, randomized, placebo controlled, multicentric trial. Sb 192-SUH study is a multicentric, placebo-controlled, double blind, randomized clinical trial addressed to assess the effect of the probiotic Sacharomyces boulardii (S.b) on the course (duration, frequency of stools and safety) of acute bloody diarrhea (non longer than 7 days duration) in ambulatory children aged 3 months - 5.99 years attending attending pediatric areas of three public hospitals in Argentina (Hospital Ramos Mejía Buenos Aires, Hospital materno infanitl de Salta, and Hospital materno infanitl de Mar del Plata). Trained pediatricians blindly prescribed a previously randomized box containing 15 of either S.b or placebo, prescribed for 7 days. Children aged 1 year or more took 500 mg / da, younger chidlren took 250 mg / day. Children were seen and cared for by the pediatrician on first visit, second (on day 3), third (on day 7). On day 14th, parents were contacted by telephone. After disclosure of data, 52 children 96 children (52 Sb; 44 placebo) adhered to the protocol. Mean duration of BD was significantly shorter in the Sb group (2.02 vs. 2.93 days; p = 0.0243). Median duration was 1.0 for Sb vs. 2.0 days for placebo (p = 0.0205). Adjusted analysis and survival curves confirmed the treatment effect. Mean bloody stools were markedly reduced from day 2 to day 5 in the Sb group. Differences were significant on day 3. Minor adverse events (fever, or vomits, and upper respiratory infections) were present in both groups with no significant differences. Stool cultures most commonly identified were Shigella and Campylobacter. <b>Conclusions </b>Sb was safe and effective in reducing the duration and intensity of BD in children under 6 years<br>