The Effect of Probiotics on Infections in Toddlers

April 22, 2012 updated by: Zealand University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Study Type

Interventional

Enrollment (Actual)

454

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Zealand
      • Holbaek, Region Zealand, Denmark, 4300
        • Paediatr. Depart., University Hospital Holbaek, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010
  • Gestational age > 36. weeks

Exclusion Criteria:

  • Chronical heart or lung conditions
  • Short Bowel Syndrome
  • CVC (Central Venous Catheter)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Dietary supplement: probiotics
placebo
Dietary supplement: probiotics
0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months
Placebo Comparator: 1
Dietary supplement: probiotics
placebo
Dietary supplement: probiotics
0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fewer infections
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
growth
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Holbaek Sygehus
Chr Hansen
Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK
Ferrosan A/S

Investigators

  • Principal Investigator: Mette L. Gyhrs, MD., ph.d student

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Estimate)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 22, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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