NCT07371819

Brief 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 Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

January 20, 2026

Last Update Submit

January 20, 2026

Conditions

Acute Bloody Diarrhea of 7 Days or Less Duration

Keywords

ACUTE BLOODY DIARRHEA. SACCHAROMYCES BOULARDII

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Proportion of patients with positive stool culture, ELISA, PCR

    At baseline

  • Safety adverse events

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

Study Arms (2)

Treatment Arm

EXPERIMENTAL
Drug: Saccharomyces boulardi (Sb)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

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

Placebo
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

Treatment Arm

Eligibility Criteria

Age3 Months - 71 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • presence of malnutrition and any other chronic or major disease,
  • previous or concomitant intake of steroids, or other immunosuppressive drugs,
  • immunocompromised

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Tetamanti in Mar del Plata (HIEMI)

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Hospital Ramos Mejía, Servicio de Pediatría (SPHRM)

Buenos Aires, Buenos Aires F.D., 1704, Argentina

Location

Hospital Materno Infantil de Salta

Salta, Salta Province, 4400, Argentina

Location

Study Officials

  • Maria Gracia Caletti, Dr

    STUDY DIRECTOR

  • Diana Kelmansky, Dr

    Statistician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 28, 2026

Study Start

January 30, 2019

Primary Completion

January 26, 2026

Study Completion

February 10, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

AR(3)