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The Effect of Probiotics on Infections in Toddlers

NCT00823056 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2012-04-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

probiotics

placebo

DIETARY_SUPPLEMENT

probiotics

0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months

Sponsors & Collaborators

  • Holbaek Sygehus

    collaborator OTHER

  • Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK

    collaborator UNKNOWN

  • Chr Hansen

    collaborator INDUSTRY

  • Ferrosan A/S

    collaborator UNKNOWN

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Mette L. Gyhrs, MD. · ph.d student

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT00823056 on ClinicalTrials.gov