Probiotics and Infections in Children Attending Day Care Centres

NCT ID: NCT01014676

Last Updated: 2011-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Tract Infections Gastrointestinal Diseases

Study Groups

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Probiotic milk

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Standard milk

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Probiotic

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

Valio Ltd

INDUSTRY

Sponsor Role lead

Principal Investigators

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Anne Pitkäranta, Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Clinical Life Sciences Inc.

Kajaani and Oulu, Province of Oulu, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 27111772 (View on PubMed)

Other Identifiers

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Valio-69

Identifier Type: -

Identifier Source: org_study_id

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