The Effect of Probiotics on Infections in Toddlers

Phase 3

Completed

• Conditions: Diarrhoea; Respiratory Diseases

• 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-22
• Last Update Posted: 2012-04-24

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

Primary Outcome Measures

Name	Time	Method
fewer infections	9 months

Secondary Outcome Measures

Name	Time	Method
growth	9 months

Trial Locations

Locations (1)

Paediatr. Depart., University Hospital Holbaek, University of Copenhagen; 🇩🇰 Holbaek, Region Zealand, Denmark