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ISRCTN
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ISRCTN30646529
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ClinicalTrials.gov identifier
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NCT00463190
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Public title
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Effect of probiotics in acute childhood diarrhea
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Scientific title
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Effect of probiotics (Bio-Three®) in children's enterocolitis
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Probiotics have been shown to be effective in the treatment of these conditions. There are many mechanisms by which probiotics enhance intestinal health, including stimulation of immunity, competition for limited nutrients, inhibition of epithelial and mucosal adherence, inhibition of epithelial invasion and production of antimicrobial substances.
Hypothesis:
Probiotics medication (Bio-Three®) could inhibit gastrointestinal infection and reduce its inflammatory response in the intestine. We plan to explore the bacterial count (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in children.
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Ethics approval
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Institutional Review Board of Chang Gung Memorial Hospital, Taoyuan, Taiwan. Date of approval: 10/01/2006
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Study design
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Randomised, double-blind (subject, caregiver, investigator), placebo-controlled, parallel-assignment, safety/efficacy, single-centre study
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Countries of recruitment
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Taiwan
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Disease/condition/study domain
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Enterocolitis
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Participants - inclusion criteria
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1. Age: From 3 months to 12 years, both male and female children
2. Clinical symptom of diarrhoea less than 3 days
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Participants - exclusion criteria
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1. Severe abdominal distension with risk of bowel perforation
2. Risk of sepsis
3. Past history of surgical operation of gastrointestinal tracts
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Anticipated start date
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01/02/2006
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Anticipated end date
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30/11/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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300
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Interventions
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Treatment group: Oral probiotics (Bio-Three®) 3 times daily for 7 days
Control group: Placebo 3 times daily for 7 days
Bio-three® contains a mixture of Bacillus mesentericus, Streptococcus faecalis and Clostridium butyricium. Total bacterial count: 1.5 x 10^8 colony forming units (cfu) per tablet.
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Primary outcome measure(s)
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To determine whether probiotics medication Bio-Three® inhibits gastrointestinal infection and reduce its inflammatory response in the intestine. The following were assessed:
1. Clinical symptoms 2 days after medication
2. Microbiology study 3 days and one week after medication
The time and the consistency of every stool were recorded and the total hospital duration was calculated.
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.
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Secondary outcome measure(s)
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Other clinical symptoms/signs including fever, vomiting, dehydration, abdominal pain, bloating, daily dietary intake and appetite were also recorded for 7 to 10 days.
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Sources of funding
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1. Chang Gung Memorial Hospital (Taiwan)
2. Maywufa Company Ltd (Taiwan)
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Trial website
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Publications
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Contact name
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Dr
Chien-Chang
Chen
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Address
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5, Fu-Hsing Street
Kwei-Shan
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City/town
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Taoyuan
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Zip/Postcode
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333
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Country
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Taiwan
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Sponsor
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Maywufa Company Ltd (Taiwan)
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Address
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5F, 167, Fu-Hsing North Road
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City/town
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Taipei
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Zip/Postcode
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105
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Country
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Taiwan
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Date applied
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25/04/2008
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Last edited
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07/05/2008
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Date ISRCTN assigned
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01/05/2008
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