Effect of probiotics in acute childhood diarrhea

ISRCTN	ISRCTN30646529
DOI	https://doi.org/10.1186/ISRCTN30646529
ClinicalTrials.gov (NCT)	NCT00463190
Protocol serial number	N/A
Sponsor	Maywufa Company Ltd (Taiwan)
Funders	Chang Gung Memorial Hospital (Taiwan), Maywufa Company Ltd (Taiwan)

Submission date: 25/04/2008
Registration date: 01/05/2008
Last edited: 31/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chien-Chang Chen
Scientific

5, Fu-Hsing Street
Kwei-Shan
Taoyuan
333
Taiwan

Study information

Primary study design	Interventional
Study design	Randomised, double-blind (subject, caregiver, investigator), placebo-controlled, parallel-assignment, safety/efficacy, single-centre study
Secondary study design	Randomised controlled trial
Scientific title	Effect of probiotics (Bio-Three®) in children's enterocolitis
Study objectives	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.
Ethics approval(s)	Institutional Review Board of Chang Gung Memorial Hospital, Taoyuan, Taiwan. Date of approval: 10/01/2006
Health condition(s) or problem(s) studied	Enterocolitis
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Other clinical symptoms/signs including fever, vomiting, dehydration, abdominal pain, bloating, daily dietary intake and appetite were also recorded for 7 to 10 days.
Completion date	30/11/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	12 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Age: From 3 months to 12 years, both male and female children 2. Clinical symptom of diarrhoea less than 3 days
Key exclusion criteria	1. Severe abdominal distension with risk of bowel perforation 2. Risk of sepsis 3. Past history of surgical operation of gastrointestinal tracts
Date of first enrolment	01/02/2006
Date of final enrolment	30/11/2007

Locations

Countries of recruitment

Taiwan

Study participating centre

5, Fu-Hsing Street

Taoyuan
333
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010	31/01/2019	Yes	No

Editorial Notes

31/01/2019: Publication reference added