Skip to main content
OpenTrials
Completed

NCT Number: NCT00823056

The Effect of Probiotics on Infections in Toddlers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diarrhoea Diarrhea Infections Pathological Conditions, Signs and Symptoms Respiratory Diseases Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Holbæk, Region Sjælland, 4300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Probiotics

Dietary Supplement

placebo

Primary outcomes

  1. fewer infections

    Time frame: 9 months

Secondary outcomes

  1. growth

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK
  • Ferrosan AS
  • Holbaek Sygehus
  • Novonesis

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 15, 2009
Registry last updated
Apr 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.