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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-60
SponsorCan Tho University of Medicine and Pharmacy

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: Saccharomyces boulardiiExperimental treatment 1 intervention
Group B: Standard treatment includes fluid replacement and zinc supplementation.Active comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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