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NCT00823056 Clinical Trial

The Effect of Probiotics on Infections in Toddlers

Diarrhoea Clinical Trial

Official title:
The Effect of Probiotics on Infections in Toddlers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00823056
Other study ID # Version 2
Secondary ID
Status Completed
Phase Phase 3
First received January 14, 2009
Last updated April 22, 2012
Start date January 2009
Est. completion date December 2011

Study information
Verified date April 2012
Source Roskilde County Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Recruitment information / eligibility
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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• probiotics
placebo
• probiotics
0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months

Locations
Country Name City State
Denmark Paediatr. Depart., University Hospital Holbaek, University of Copenhagen Holbaek Region Zealand

Sponsors (5)
Lead Sponsor Collaborator
Roskilde County Hospital Chr Hansen A/S, Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK, Ferrosan A/S, Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary fewer infections 9 months No
Secondary growth 9 months No
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