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The Effect of Probiotics on Infections in Toddlers

Phase 3
Completed
Conditions
Diarrhoea
Respiratory Diseases
Interventions
Dietary Supplement: probiotics
Registration Number
NCT00823056
Lead Sponsor
Zealand University Hospital
Brief 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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
454
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1probiotics-
2probiotics-
Primary Outcome Measures
NameTimeMethod
fewer infections9 months
Secondary Outcome Measures
NameTimeMethod
growth9 months

Trial Locations

Locations (1)

Paediatr. Depart., University Hospital Holbaek, University of Copenhagen

🇩🇰

Holbaek, Region Zealand, Denmark

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