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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Bloody Diarrhea of 7 Days or Less Duration
• Intervention / Treatment: Drug: Saccharomyces boulardi (Sb); Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Hospital Tetamanti in Mar del Plata (HIEMI)
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, 1704
      • Hospital Ramos Mejía, Servicio de Pediatría (SPHRM)
  • Salta Province
    • Salta, Salta Province, Argentina, 4400
      • Hospital Materno Infantil de Salta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all children between 0.25 and 5.99 years
• attending emergency clinic because of acute diarrhea,
• showing stools with presence of blood,
• whose parents were adequately informed, and signed the corresponding consent

Exclusion Criteria:

• diarrhea lasting more than 7 days at inclusion
• presence of malnutrition and any other chronic or major disease,
• previous or concomitant intake of steroids, or other immunosuppressive drugs,
• immunocompromised

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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
Experimental: Treatment Arm	Drug: Saccharomyces boulardi (Sb); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of bloody diarrhea	The number of days of bloody diarrhea between SB and placebo groups	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	From baseline to end of follow-up (Day 14)
Number of bloody stools per day	Number of stools in children with blood in stools	From baseline to end of follow-up (Day 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline
Safety adverse events	Differences in adverse events between both groups	From baseline to end of follow-up (Day 14)

Collaborators and Investigators

• Sponsor: Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan
• Investigators: Study Director: Maria Gracia Caletti, Dr; Principal Investigator: Diana Kelmansky, Dr, Statistician

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Estimated): January 26, 2026
• Study Completion (Estimated): February 10, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ACUTE BLOODY DIARRHEA. SACCHAROMYCES BOULARDII
• Other Study ID Numbers: Sb192-SUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No