The Treatment Effect of Bio-Three on Children With Enteritis

Phase 4

Completed

• Conditions: Gastroenteritis; Diarrhea
• Interventions: Drug: Bio-three

• Registration Number: NCT01480947
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-11
• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Study First Posted: 2011-11-29
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio-Three	Bio-three	add-on treatment of the probiotics (Bio-three)
control treatment	Bio-three	control treatment (intravenous fluid, oral rice and half strength milk formula)

Primary Outcome Measures

Name	Time	Method
Quantitative Vesikari scales and qualitative severe diarrhea	7 days	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

Trial Locations

Locations (1)

Department of Pediatrics, Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan