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Not yet recruitingNCT07813182Updated Sep 10, 2026

Efficacy and Safety of Saccharomyces Boulardii in Treatment of Acute Diarrhea in Children Aged 6 Months to 5 Years Old

An interventional study of Saccharomyces Boulardii Probiotic Supplement and The child will be treated with standard method in Acute Diarrhea, sponsored by Can Tho University of Medicine and Pharmacy. Not yet recruiting at 1 site in Vietnam. Open to participants aged 6 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
6 Months to 60 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acute Diarrhea

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Keywords

  • Acute diarrhea
  • Saccharomyces Boulardii
  • Children
  • Probiotics
  • Vietnam
03

In context

Diarrhea

877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.

This study's planned enrollment of 206 is above the median of 137 across 738 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age from 6 months to 5 years old
  • Children are diagnosed with acute diarrhea according to WHO criteria.

Exclusion criteria

Exclusion Criteria:

  • 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 drugs.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
206 participants (estimated)

Study arms

  • Experimental
    Saccharomyces boulardii

    Saccharomyces boulardii is a type of yeast that helps to quickly restore the intestinal mucosal barrier and the gut microbiome, significantly shortening hospital stays.

    Drug: Saccharomyces Boulardii Probiotic Supplement

  • Active comparator
    Standard treatment includes fluid replacement and zinc supplementation.

    Treatment should follow standard protocols with fluid replacement and zinc supplementation, but no additional Saccharomyces boulardii should be added until discharge.

    Drug: The child will be treated with standard method

Interventions

  • Children will receive standard treatment including fluid and zinc supplementation. In addition, they will receive Saccharomyces boulardii supplementation from admission to discharge.

  • DrugThe child will be treated with standard method

    Children will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics.

06

What researchers measure

Primary outcomes

  1. Duration of diarrhea

    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.

    Time frame: Immediately after the intervention

  2. The frequency of stool

    Total number of bowel movements per day

    Time frame: At day 1, 3, 5

  3. 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.

    Time frame: At day 1, 3, 5

Secondary outcomes

  1. Length of hospitalization

    The total length of hospitalization, measured in days

    Time frame: Immediately after the intervention

  2. Adverse events

    The occurrence of adverse events during treatment, including such as rash and bloating.

    Time frame: Immediately after the intervention

  3. Cost effectiveness

    Total Cost per child from date of admission until discharge

    Time frame: Immediately after the intervention

  4. Rate of Hospital readmission

    The proportion of participants who were readmitted to the hospital after discharge

    Time frame: At day 14 and 28 after discharge from the hospital.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2028, 23 months later.

Of 129 non-industry interventional studies with no phase under Diarrhea, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 23 months is above that.

Counting every sponsor, half of 164 studies reached it within 14 months; a quarter within 5 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 10, 2026
StartEst.
Aug 31, 2026
Primary completionEst.
Aug 30, 2028
CompletionEst.
Aug 30, 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07813182
Lead sponsor
Can Tho University of Medicine and Pharmacy
Responsible party
Nguyễn Thị Phương Thão (Principal Investigator, Can Tho University of Medicine and Pharmacy) — Principal investigator
First posted
Sep 10, 2026
Start date
Aug 31, 2026 (estimated)
Primary completion
Aug 30, 2028 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Thao Thi Phuong Nguyen, M.D
Contact
Whynottheo@gmail.com
+84789212603
Duc Long Tran, Ph.D
Contact
tdlong@ctump.edu.vn
Thao Thi Phuong Nguyen, M.D
study chair · Can Tho University of Medicine and Pharmacy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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