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Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare

NCT02180581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2016-08-24

No results posted yet for this study

Summary

The aim of the intervention is to examine the effect of a combination of the two bacterial strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic manifestations in small children, and how a combination of BB-12 and LGG affects the immune system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.

Conditions

  • Days Absent From Daycare
  • Respiratory Tract Infections
  • Gastrointestinal Infections
  • Allergy

Interventions

DIETARY_SUPPLEMENT

Probiotic (2 * 10^9 cfu/day)

Combination of two probiotics (2 \* 10\^9 cfu/day) or probiotics for 6 months

DIETARY_SUPPLEMENT

Placebo

Placebo for 6 months

Sponsors & Collaborators

  • The Danish Council for Strategic Research

    collaborator OTHER

  • Chr Hansen

    collaborator INDUSTRY

  • Technical University of Denmark

    collaborator OTHER

  • University of Bergen

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Statens Serum Institut

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
14 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02180581 on ClinicalTrials.gov