Acute DiarrheaNCT07813182
Efficacy and Safety of Saccharomyces Boulardii in Treatment of Acute Diarrhea in Children Aged 6 Months to 5 Years Old
A study testing Saccharomyces Boulardii Probiotic Supplement and The child will be treated with standard method in people with Acute Diarrhea, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
This study aimed to evaluate the effectiveness of saccharomyces-based treatment in children with acute diarrhea aged 6 months to 5 years compared to children treated with standard methods. Read more about this study
- Who is it for?
- Ages 6 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Diarrhea
- What is being tested?
- Saccharomyces Boulardii Probiotic Supplement and The child will be treated with standard method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteVietnam
- Study dates
- 31 Aug 2026to 30 Aug 2028
- Phase
- Interventional
- 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 6 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age from 6 months to 5 years old
- Children are diagnosed with acute diarrhea according to WHO criteria.
Who cannot join
- Bloody, mucous stools.
- Signs of sepsis requiring admission to the Intensive Care Unit.
- Currently suffering from chronic diseases such as cow's milk protein allergy, nephrotic syndrome, immunodeficiency, and systemic diseases.
- Currently using immunosuppressant drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Duc Long Tran, Ph.D contact
Vietnam1 site
Can Tho University of Medicine and Pharmacy
Can Tho, 900000
Duc Long Tran, Ph.D, +842923739730, tdlong@ctump.edu.vn
About this study
This study aimed to evaluate the effectiveness of saccharomyces-based treatment in children with acute diarrhea aged 6 months to 5 years compared to children treated with standard methods.
Read the detailed description
A total of 206 children diagnosed with acute diarrhea will be evaluated and divided into two groups based on a random distribution list: Group A and Group B.
Group A will be treated with standard methods including fluid replacement and zinc according to the Ministry of Health's protocol.
Group B will be treated similarly to Group A, but with the addition of Saccharomyces boulardii at a dose of 250 to 750 mg per day until discharge.
Both groups of children will receive the same counseling and monitoring, with guidance provided to parents.
Caregivers are advised to record symptoms and stool diaries daily.
- Conditions
- Acute Diarrhea
- Being tested
- Saccharomyces Boulardii Probiotic Supplement, The child will be treated with standard method
- Keywords
- Acute diarrhea, Saccharomyces Boulardii, Children, Probiotics, Vietnam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces Boulardii Probiotic SupplementDrug
Children will receive standard treatment including fluid and zinc supplementation. In addition, they will receive Saccharomyces boulardii supplementation from admission to discharge.
The child will be treated with standard methodDrug
Children will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces boulardii | Experimental | Saccharomyces boulardii is a type of yeast that helps to quickly restore the intestinal mucosal barrier and the gut microbiome, significantly shortening hospital stays. Receives: Drug: Saccharomyces Boulardii Probiotic Supplement |
| Standard treatment includes fluid replacement and zinc supplementation. | Active comparator | Treatment should follow standard protocols with fluid replacement and zinc supplementation, but no additional Saccharomyces boulardii should be added until discharge. Receives: Drug: The child will be treated with standard method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
The cessation of acute diarrhea is determined when children met following criteria:
- Passing soft or formed stools twice in a row.
- No bowel movements recorded for 12 consecutive hours.
- Stool consistency returns to normal, corresponding to categories 3 to 5 on the Bristol stool scale.
Measured: Immediately after the intervention
The frequency of stool
Total number of bowel movements per day
Measured: At day 1, 3, 5
Stool consistency assessed by Bristol stool chart
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool.
Measured: At day 1, 3, 5
Secondary outcomes (4)
Length of hospitalization
The total length of hospitalization, measured in days
Measured: Immediately after the intervention
Adverse events
The occurrence of adverse events during treatment, including such as rash and bloating.
Measured: Immediately after the intervention
Cost effectiveness
Total Cost per child from date of admission until discharge
Measured: Immediately after the intervention
Rate of Hospital readmission
The proportion of participants who were readmitted to the hospital after discharge
Measured: At day 14 and 28 after discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group received Saccharomyces boulardii, while the control group received standard treatment.
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyễn Thị Phương Thão, Can Tho University of Medicine and Pharmacy
- Investigators
- Thao Thi Phuong Nguyen, M.D, Study chair, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813182
- Sponsor's protocol ID
- 2857/QĐ-ĐHYDCT
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Saccharomyces Boulardii in Treatment of Acute Diarrhea in Children Aged 6 Months to 5 Years Old
- ClinicalTrials.gov ID
- NCT07813182
- Acronym / sponsor ID
- 2857/QĐ-ĐHYDCT
- Conditions
- Acute Diarrhea
- Keywords
- Acute diarrhea, Saccharomyces Boulardii, Children, Probiotics, Vietnam
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 10 Sep 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.
This study aimed to evaluate the effectiveness of saccharomyces-based treatment in children with acute diarrhea aged 6 months to 5 years compared to children treated with standard methods.
Detailed description
A total of 206 children diagnosed with acute diarrhea will be evaluated and divided into two groups based on a random distribution list: Group A and Group B.
Group A will be treated with standard methods including fluid replacement and zinc according to the Ministry of Health's protocol.
Group B will be treated similarly to Group A, but with the addition of Saccharomyces boulardii at a dose of 250 to 750 mg per day until discharge.
Both groups of children will receive the same counseling and monitoring, with guidance provided to parents.
Caregivers are advised to record symptoms and stool diaries daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group received Saccharomyces boulardii, while the control group received standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces boulardii | Experimental | Drug: Saccharomyces Boulardii Probiotic SupplementSaccharomyces boulardii is a type of yeast that helps to quickly restore the intestinal mucosal barrier and the gut microbiome, significantly shortening hospital stays. |
| Standard treatment includes fluid replacement and zinc supplementation. | Active comparator | Drug: The child will be treated with standard methodTreatment should follow standard protocols with fluid replacement and zinc supplementation, but no additional Saccharomyces boulardii should be added until discharge. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age from 6 months to 5 years old
- Children are diagnosed with acute diarrhea according to WHO criteria.
Key exclusion criteria (4 listed)
- Bloody, mucous stools.
- Signs of sepsis requiring admission to the Intensive Care Unit.
- Currently suffering from chronic diseases such as cow's milk protein allergy, nephrotic syndrome, immunodeficiency, and systemic diseases.
- Currently using immunosuppressant drugs.
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 Boulardii Probiotic SupplementChildren will receive standard treatment including fluid and zinc supplementation. In addition, they will receive Saccharomyces boulardii supplementation from admission to discharge. | Drug | Saccharomyces boulardii |
| The child will be treated with standard methodChildren will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics. | Drug | Standard treatment includes fluid replacement and zinc supplementation. |
Primary outcome
Duration of diarrhea
Time frame: Immediately after the intervention
The cessation of acute diarrhea is determined when children met following criteria: 1. Passing soft or formed stools twice in a row. 2. No bowel movements recorded for 12 consecutive hours. 3. Stool consistency returns to normal, corresponding to categories 3 to 5 on the Bristol stool scale.
The frequency of stool
Time frame: At day 1, 3, 5
Total number of bowel movements per day
Stool consistency assessed by Bristol stool chart
Time frame: At day 1, 3, 5
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool.
4 secondary outcomes
Length of hospitalization
Time frame: Immediately after the intervention
Adverse events
Time frame: Immediately after the intervention
Cost effectiveness
Time frame: Immediately after the intervention
Rate of Hospital readmission
Time frame: At day 14 and 28 after discharge from the hospital.
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 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Diarrhea
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Recruiting
Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
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Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3
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Rural Water Filtration and Health Study
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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.
Duc Long Tran, Ph.D contact
Thao Thi Phuong Nguyen, M.D study chair
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces Boulardii Probiotic Supplement and The child will be treated with standard method in people with Acute Diarrhea, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 2 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Thao Thi Phuong Nguyen, M.D (+84789212603, Whynottheo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of diarrhea (time frame: Immediately after the intervention). 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 10 Sep 2026.