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CompletedNCT01014676Updated Jul 7, 2011

Probiotics and Infections in Children Attending Day Care Centres

A Phase 3 interventional study of Probiotic and Placebo in Respiratory Tract Infections and Gastrointestinal Diseases, sponsored by Valio Ltd. Completed at 1 site in Finland. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2011-07-07.

Sponsored by Valio Ltd · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Ages
2 Years to 6 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.

02

Conditions studied

  • Respiratory Tract Infections
  • Gastrointestinal Diseases

Keywords

  • Costs and Cost Analysis
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Valio Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 6 Years
Sexes eligible
All

Inclusion criteria

  • Age 2 to 6 years in the beginning of the intervention
  • Attendance at a day care centre participating in the study (5 days a week)

Exclusion criteria

Exclusion Criteria:

  • Milk allergy or lactose intolerance
  • Congenital heart diseases that requires regular medication
  • Malign diseases
  • Cytostatic treatment
  • Use of biological rheumatic medication
  • Continuous microbial medication
  • Regular use of oral corticosteroids (inhalable accepted)
  • Diabetes
  • Simultaneous participation in other clinical trials
05

Study design

Phase
Phase 3

Study arms

  • Active comparator
    Probiotic milk

    Dietary Supplement: Probiotic

  • Placebo comparator
    Standard milk

    Other: Placebo

Interventions

  • Dietary supplementProbiotic
  • OtherPlacebo
06

Study locations

1 site
  • Clinical Life Sciences Inc.
    Kajaani and Oulu, Province of Oulu, Finland
07

References and documents

Publications

  • Korpela K, Salonen A, Virta LJ, Kumpu M, Kekkonen RA, de Vos WM. Lactobacillus rhamnosus GG Intake Modifies Preschool Children's Intestinal Microbiota, Alleviates Penicillin-Associated Changes, and Reduces Antibiotic Use. PLoS One. 2016 Apr 25;11(4):e0154012. doi: 10.1371/journal.pone.0154012. eCollection 2016. PubMed 27111772 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01014676
Lead sponsor
Valio Ltd
Collaborators
University of Helsinki
First posted
Nov 17, 2009
Last update
Jul 7, 2011

Study contacts

Anne Pitkäranta, Professor
principal investigator · Helsinki University Central Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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