A Phase 4 interventional study of Saccharomyces boulardi (Sb) and Placebo in Acute Bloody Diarrhea of 7 Days or Less Duration, sponsored by Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan. Active, not recruiting at 3 sites in Argentina. Open to participants aged 3 Months to 71 Months. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan · Phase 4, Interventional, and Treatment
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 :
Patients with acute bloody diarrhea were prescribed randomly and blindly placebo or Saccharomyces boulardii 500 mg /day seven days (250 mg for children between 0.25 - 1.00 years),and were seen in outpatient clinics of three hospitals at days 1, 3, and 7. On day 14 they were contacted by telephone call. Parents registered daily number of stools, with or without diarrhea, and any new symptom appearing during follow up.
This is the only study on the registry with Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Saccharomyces boulardi (Sb)
Drug: Placebo
Drug: Saccharomyces Boulardii 250 MG Saccharomyces boulardi (Sb) 250 mg dose to be administered to the patient : - twice a day, to children from older than 1.0 year, up to 5.99 years, - or once a day to children 1year old or younger
Drug: Placebo Placebo to be administered to the patient : -twice a day, to children from older than 1.0 year, up to 5.99 years, - or once a day to children 1year old or younger
Duration of bloody diarrhea
The number of days of bloody diarrhea between SB and placebo groups
Time frame: From baseline to end of follow-up (Day 14)
Number of total stools per day
Number of stools in children with or without blood in stools
Time frame: From baseline to end of follow-up (Day 14)
Number of bloody stools per day
Number of stools in children with blood in stools
Time frame: From baseline to end of follow-up (Day 14)
Proportion of patients with positive stool culture, ELISA, PCR
Stool culture for O157:H7 or non-O157:H7 enterohemorrhagic E. coli, PCR and/or ELISA for verotoxins and detection of Campylobacter spp, Shigella spp, Salmonella spp and other pathogens
Time frame: At baseline
Safety adverse events
Differences in adverse events between both groups
Time frame: From baseline to end of follow-up (Day 14)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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