About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age from 6 months to 5 years old
Children are diagnosed with acute diarrhea according to WHO criteria.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Saccharomyces Boulardii Probiotic Supplement
DrugChildren 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
DrugChildren will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics.
Treatment groups
Trial outcomes
Primary outcomes
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.
The frequency of stool
Total number of bowel movements per day
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.
Secondary outcomes
Length of hospitalization
The total length of hospitalization, measured in days
Adverse events
The occurrence of adverse events during treatment, including such as rash and bloating.
Cost effectiveness
Total Cost per child from date of admission until discharge
Rate of Hospital readmission
The proportion of participants who were readmitted to the hospital after discharge
Sponsors and contacts
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