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NCT Number: NCT07813182

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

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.

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Key information

Conditions

Acute Diarrhea

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Saccharomyces Boulardii Probiotic Supplement

Drug

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 method

Drug

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

Primary outcomes

  1. Duration of diarrhea

    Time frame: Immediately after the intervention

    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.

  2. The frequency of stool

    Time frame: At day 1, 3, 5

    Total number of bowel movements per day

  3. 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.

Secondary outcomes

  1. Length of hospitalization

    Time frame: Immediately after the intervention

    The total length of hospitalization, measured in days

  2. Adverse events

    Time frame: Immediately after the intervention

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

  3. Cost effectiveness

    Time frame: Immediately after the intervention

    Total Cost per child from date of admission until discharge

  4. Rate of Hospital readmission

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Duc Long Tran, Ph.D

CONTACT

[email protected]

Thao Thi Phuong Nguyen, M.D

CONTACT

[email protected]

+84789212603

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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