Clinical Trial

Effect of Saccharomyces Boulardii CNCM I-745 (Sb) on Bloody Diarrhea in Children. A Double Blind, Randomized, Controlled Study ( Sb192-SUH )

Active, Not Recruiting Phase 4
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Summary
Acute diarrhea (AD) is one of the commonest illnesses in children. A particularly severe form of diarrhea is bloody diarrhea (BD). Saccharomyces boulardii CNCM I-745 is a probiotic with demonstrated efficacy in children with acute diarrhea; however, evidence regarding its use in bloody diarrhea (BD) is lacking. This project aims to assess the efficacy and safety of Saccharomyces boulardii CNCM I-745 on bloody diarrhea in children. The study objective are : • To assess the efficacy of Sacharomyces Boulardi (SB) on acute bloody diarrhea in children aged 0 - 5 years. Indicators: duration of bloody diarrhea, daily frequency of stools with blood, daily frequency of total stools with or without blood during follow up. • To assess the most frequent bacterial agents • To assess the safety of the product. The study is a double blind, controlled trial (SB or placebo), with two arms parallel, randomized design, carried out on outpatient clinic because of acute bloody diarrhea.
Trial Details
NCT Number NCT07371819
Lead Sponsor Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan
Conditions Acute Bloody Diarrhea of 7 Days or Less Duration
Enrollment 140 participants
Start Date 2019-01-30
Primary Completion 2026-01-26 (estimated)
Study Completion 2026-02-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-28