NCT01480947

The Treatment Effect of Bio-Three on Children With Enteritis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: All
• Age: 3 Months – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroenteritis
• Diarrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-11-29
• Last updated: 2011-11-29

Locations

1 site across 1 country: Taiwan