Effect of probiotics in acute childhood diarrhea

Not Applicable

Completed

• Conditions: Enterocolitis; Digestive System; Diarrhoea and gastroenteritis of presumed infectious origin

• Registration Number: ISRCTN30646529
• Lead Sponsor: Maywufa Company Ltd (Taiwan)

Brief Summary

1. 2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20135748 (added 31/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-11-30
• Study Start: 2008-05-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Age: From 3 months to 12 years, both male and female children
2. Clinical symptom of diarrhoea less than 3 days

Exclusion Criteria

1. Severe abdominal distension with risk of bowel perforation
2. Risk of sepsis
3. Past history of surgical operation of gastrointestinal tracts

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To determine whether probiotics medication Bio-Three® inhibits gastrointestinal infection and reduce its inflammatory response in the intestine. The following were assessed:<br> 1. Clinical symptoms 2 days after medication<br> 2. Microbiology study 3 days and one week after medication<br><br> The time and the consistency of every stool were recorded and the total hospital duration was calculated.<br><br> Severity of diarrhoea was evaluated according to the following parameters: number of stools, fecal consistency, the presence or absence of mucus, and blood in stools.<br>

Secondary Outcome Measures

Name	Time	Method
Other clinical symptoms/signs including fever, vomiting, dehydration, abdominal pain, bloating, daily dietary intake and appetite were also recorded for 7 to 10 days.