Skip to content

The Effect of Probiotics on Infections in Toddlers

The Effect of Probiotics on Infections in Toddlers

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00823056
Enrollment
454
Registered
2009-01-15
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhoea, Respiratory Diseases

Keywords

Probiotics, Infections, Children

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.

Interventions

DIETARY_SUPPLEMENTprobiotics

placebo

Sponsors

Holbaek Sygehus
CollaboratorOTHER
Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK
CollaboratorUNKNOWN
Chr Hansen
CollaboratorINDUSTRY
Ferrosan A/S
CollaboratorUNKNOWN
Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Months to 7 Months
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
fewer infections9 months

Secondary

MeasureTime frame
growth9 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026