Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07371819

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Acute Bloody Diarrhea of 7 Days or Less Duration

Age range

3 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Tetamanti in Mar del Plata (HIEMI), Mar del Plata, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saccharomyces boulardi (Sb)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Duration of bloody diarrhea

    Time frame: From baseline to end of follow-up (Day 14)

    The number of days of bloody diarrhea between SB and placebo groups

  2. Number of total stools per day

    Time frame: From baseline to end of follow-up (Day 14)

    Number of stools in children with or without blood in stools

  3. Number of bloody stools per day

    Time frame: From baseline to end of follow-up (Day 14)

    Number of stools in children with blood in stools

Secondary outcomes

  1. Proportion of patients with positive stool culture, ELISA, PCR

    Time frame: At baseline

    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

  2. Safety adverse events

    Time frame: From baseline to end of follow-up (Day 14)

    Differences in adverse events between both groups

Sponsors and collaborators

Lead sponsor

Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.