MedTrace Logo

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

NCT07371819 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Acute Bloody Diarrhea of 7 Days or Less Duration

Interventions

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

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Maria Gracia Caletti, Dr

  • Diana Kelmansky, Dr · Statistician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2026-01-26
Completion
2026-02-10

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07371819 on ClinicalTrials.gov