NCT01014676

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

First QC Date

November 16, 2009

Last Update Submit

July 6, 2011

Conditions

Respiratory Tract InfectionsGastrointestinal Diseases

Keywords

Costs and Cost Analysis

Study Arms (2)

Probiotic milk

ACTIVE COMPARATOR
Dietary Supplement: Probiotic

Standard milk

PLACEBO COMPARATOR
Other: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT
Probiotic milk
PlaceboOTHER
Standard milk

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Life Sciences Inc.

Kajaani and Oulu, Province of Oulu, Finland

Location

Related Publications (1)

  • 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.

    PMID: 27111772DERIVED

MeSH Terms

Conditions

Respiratory Tract InfectionsGastrointestinal Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Anne Pitkäranta, Professor

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

FI(1)