Diarrhoea Clinical Trial
Official title:
The Effect of Probiotics on Infections in Toddlers
Verified date | April 2012 |
Source | Roskilde County Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials
indicate that probiotics might have an effect in preventing common infection diseases in
children.
The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a
daily intake of a suspension containing probiotics in a period of 9 months, the incidence of
diarrhoea and respiratory diseases can be reduced.
Status | Completed |
Enrollment | 454 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 7 Months |
Eligibility |
Inclusion Criteria: - Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010 - Gestational age > 36. weeks Exclusion Criteria: - Chronical heart or lung conditions - Short Bowel Syndrome - CVC (Central Venous Catheter) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Paediatr. Depart., University Hospital Holbaek, University of Copenhagen | Holbaek | Region Zealand |
Lead Sponsor | Collaborator |
---|---|
Roskilde County Hospital | Chr Hansen A/S, Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK, Ferrosan A/S, Holbaek Sygehus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fewer infections | 9 months | No | |
Secondary | growth | 9 months | No |
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