Acute Diarrhea
Conditions
Keywords
Acute diarrhea, Saccharomyces Boulardii, Children, Probiotics, Vietnam
Brief 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.
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.
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.
Sponsors
Can Tho University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The blinding method was not performed.
Intervention model description
The intervention group received Saccharomyces boulardii, while the control group received standard treatment.
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea | 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 | At day 1, 3, 5 | Total number of bowel movements per day |
| Stool consistency assessed by Bristol stool chart | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | Immediately after the intervention | The total length of hospitalization, measured in days |
| Adverse events | Immediately after the intervention | The occurrence of adverse events during treatment, including such as rash and bloating. |
| Cost effectiveness | Immediately after the intervention | Total Cost per child from date of admission until discharge |
| Rate of Hospital readmission | At day 14 and 28 after discharge from the hospital. | The proportion of participants who were readmitted to the hospital after discharge |
Countries
Vietnam
Contacts
CONTACTThao Thi Phuong Nguyen, M.D
CONTACTDuc Long Tran, Ph.D
STUDY_CHAIRThao Thi Phuong Nguyen, M.D
Can Tho University of Medicine and Pharmacy
Outcome results
None listed