The Treatment Effect of Bio-Three on Children With Enteritis

Study Overview
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Brief Summary
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Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are infected by rotavirus or salmonella. Base on the past researches, there is benefit effect of probiotics on patients with diarrhea or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three independent probiotics, will be used in patients with acute diarrhea. This is a single site, controlled clinical research. About 80 patients will be enrolled into this study to evaluate the benefit effect of bio-Three among patients with acute enteritis due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.

Detailed Description
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Intervention: Subjects were randomly assigned to receive control treatment (intravenous fluid, oral rice and half strength milk formula) or add-on treatment of the probiotics (Bio-three®) to the control treatment. Main outcome measures: Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Exclusion criteria included immunodeficiency, severe abdominal distension with risk of bowel perforation, severe infection or sepsis, history of gastrointestinal tract surgery, and probiotics use in the preceding 1 week.

Official Title
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The Treatment Effect of Bio-Three on Children With Enteritis Due to Salmonella or Rotavirus or Any Unknown Reason

Conditions
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Gastroenteritis, Diarrhea

Intervention / Treatment
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* Drug: Bio-three


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical symptom of diarrhea less than 3 days Exclusion Criteria: Severe abdominal distension with risk of bowel perforation Risk for sepsis Past history with surgical operation of gastrointestinal tracts immunodeficiency probiotics use in the preceding 1 week

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bio-Three<br>add-on treatment of the probiotics (Bio-three) | Drug: Bio-three<br>* oral Bio-three three times daily for 7 days, Bio-three dosage plan: 1) patients aged 6 years old, 1 tablet t.i.d.; 2) patients aged between 6 and 12 years old, 2 tablets t.i.d.; 3) patients aged 12 years old, 3 tablets t.i.d.<br>|
| No Intervention: control treatment<br>control treatment (intravenous fluid, oral rice and half strength milk formula) | Drug: Bio-three<br>* oral Bio-three three times daily for 7 days, Bio-three dosage plan: 1) patients aged 6 years old, 1 tablet t.i.d.; 2) patients aged between 6 and 12 years old, 2 tablets t.i.d.; 3) patients aged 12 years old, 3 tablets t.i.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Vesikari scales and qualitative severe diarrhea | Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Severity of diarrhea was evaluated according to the following features: volume of stools, fecal consistency, and frequency. Other clinical symptoms or signs, including fever, vomiting, daily intake, dehydration, and treatment were also assessed | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, pediatric, salmonella, rotavirus, gastroenteritis