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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Diarrhea
• Intervention / Treatment: Drug: Saccharomyces Boulardii Probiotic Supplement; Drug: The child will be treated with standard method

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 Type: Interventional
• Enrollment (Estimated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thao Thi Phuong Nguyen, M.D; Phone Number: +84789212603; Email: Whynottheo@gmail.com
• Study Contact Backup: Name: Duc Long Tran, Ph.D; Email: tdlong@ctump.edu.vn

Study Locations

• Vietnam
  • Can Tho, Vietnam, 900000
    • Can Tho University of Medicine and Pharmacy
    • Contact: Duc Long Tran, Ph.D; Phone Number: +842923739730; Email: tdlong@ctump.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Children will receive standard treatment including fluid and zinc supplementation. In addition, they will receive Saccharomyces boulardii supplementation from admission to discharge.
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; Children will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the intervention
The frequency of stool	Total number of bowel movements per day	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.	At day 1, 3, 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospitalization	The total length of hospitalization, measured in days	Immediately after the intervention
Adverse events	The occurrence of adverse events during treatment, including such as rash and bloating.	Immediately after the intervention
Cost effectiveness	Total Cost per child from date of admission until discharge	Immediately after the intervention
Rate of Hospital readmission	The proportion of participants who were readmitted to the hospital after discharge	At day 14 and 28 after discharge from the hospital.

Collaborators and Investigators

• Sponsor: Can Tho University of Medicine and Pharmacy
• Investigators: Study Chair: Thao Thi Phuong Nguyen, M.D, Can Tho University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: August 31, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Children; Probiotics; Vietnam; Saccharomyces Boulardii; Acute diarrhea
• Other Study ID Numbers: 2857/QĐ-ĐHYDCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No