The Treatment Effect of Bio-Three on Children With Enteritis

Diarrhea Clinical Trial

— Bio-three  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480947
• Other study ID #: VGHKS98-CT1-11
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2011
• Last updated: November 28, 2011
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Gastroenteritis

Intervention

Drug:
• Bio-three
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.

Locations

Country	Name	City	State
Taiwan	Department of Pediatrics, Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes