Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the effect of mothers' application of yogurt probiotic bacteria on relieving their young children's acute gastroenteritis in children had two to five years old. The main hypothesis is children with acute gastroenteritis who receive yogurt probiotic bacteria exhibit less diarrhea, vomiting and dehydration than those who don't.The study subjects were divided into two equal groups (probiotic study group and control group).

Official Title
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Effect of Mothers' Application of Yogurt Probiotic Bacteria on Relieving Their Young Children's Acute Gastroenteritis

Conditions
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Acute Gastroenteritis

Intervention / Treatment
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* Dietary Supplement: yogurt with probiotic bacteria


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly admitted children with no or some dehydration and with acute gastroenteritis. Exclusion Criteria: bloody watery diarrhea

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Children with acute gastroenteritis received standard hospital care and the prescribed medication of control group for acute gastroenteritis. | |
| Experimental: Probiotic Study Group<br>Children with acute gastroenteritis received fresh probiotic yogurt (1st day of production) for three consecutive days in addition to standard hospital care and prescribed medication for acute gastroenteritis. | Dietary Supplement: yogurt with probiotic bacteria<br>* Children in probiotic study group were received 15 mg/kg of market available fresh probiotic yogurt after stopping vomiting every four to six hours for three consecutive days beside to the standard hospital care and the prescribed medication for acute gastroenteritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of diarrhea | yes/no | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Consistency of diarrhea | Soft/ watery/ abnormal constitute | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Amount of diarrhea | Small / moderate/ large/ severe | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Frequency of diarrhea | times /day. | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Odor of diarrhea | No odor/ offensive odor | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Duration of diarrhea | /days. | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Experience of Vomiting | Yes/ no | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Amount of Vomiting | Small / moderate/ large/ severe | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Frequency of Vomiting | times /day. | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Consistency of Vomiting | Soft/ watery/ abnormal constitute | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Duration of Vomiting | /days. | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| General condition of child | Normal/ Restless, irritable/ Lethargic or unconscious | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Eye | Normal/ Sunken eyes/ Very Sunken eyes | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Thirsty | Drink normally/ Drinks eagerly, thirsty/ Drinks poorly or unable to drink | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 
| Skin pinch | Goes back quickly/ Goes back slowly/ Goes back very slowly | before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yogurt Probiotic Bacteria, young Children, Gastroenteritis