Acute Bloody Diarrhea of 7 Days or Less DurationPhase 4NCT07371819
Effect of Saccharomyces Boulardii CNCM I-745 (Sb) on Bloody Diarrhea in Children. A Double Blind, Randomized, Controlled Study ( Sb192-SUH )
A Phase 4 study testing Saccharomyces boulardi (Sb) in people with Acute Bloody Diarrhea of 7 Days or Less Duration, run by Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan at 3 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 71 months
- Conditions the study is for
- Acute Bloody Diarrhea of 7 Days or Less Duration
- What is being tested?
- Saccharomyces boulardi (Sb)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 3 sitesArgentina
- Study dates
- 30 Jan 2019to 10 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Hospital Ramos Mejía, Servicio de Pediatría (SPHRM)
Buenos Aires, Buenos Aires F.D., 1704
Hospital Tetamanti in Mar del Plata (HIEMI)
Mar del Plata, Buenos Aires, 7600
Hospital Materno Infantil de Salta
Salta, Salta Province, 4400
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Saccharomyces boulardi (Sb), Placebo
- Keywords
- ACUTE BLOODY DIARRHEA. SACCHAROMYCES BOULARDII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Saccharomyces boulardi (Sb) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of bloody diarrhea
The number of days of bloody diarrhea between SB and placebo groups
Measured: 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
Measured: From baseline to end of follow-up (Day 14)
Number of bloody stools per day
Number of stools in children with blood in stools
Measured: From baseline to end of follow-up (Day 14)
Secondary outcomes (2)
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
Measured: At baseline
Safety adverse events
Differences in adverse events between both groups
Measured: From baseline to end of follow-up (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start30 Jan 2019
- Primary completion26 Jan 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bloody Diarrhea of 7 Days or Less DurationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Gracia Caletti, Dr, Study directorDiana Kelmansky, Dr, Principal investigator, Statistician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371819
- Sponsor's protocol ID
- Sb192-SUH
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Saccharomyces Boulardii CNCM I-745 (Sb) on Bloody Diarrhea in Children. A Double Blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07371819
- Acronym / sponsor ID
- Sb192-SUH
- Keywords
- ACUTE BLOODY DIARRHEA. SACCHAROMYCES BOULARDII
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundación Hospital de Pediatría Prof. Dr. Juan P. GarrahanUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 26 Jan 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Saccharomyces boulardi (Sb) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 3 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Treatment Arm |
| PlaceboDrug: 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 | Drug | Placebo |
Primary outcome
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
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
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
2 secondary outcomes
Proportion of patients with positive stool culture, ELISA, PCR
Time frame: At baseline
Safety adverse events
Time frame: From baseline to end of follow-up (Day 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Gracia Caletti, Dr study director
Diana Kelmansky, Dr principal investigator
Statistician
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saccharomyces boulardi (Sb) in people with Acute Bloody Diarrhea of 7 Days or Less Duration, run by Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan at 3 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of bloody diarrhea (time frame: From baseline to end of follow-up (Day 14)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.