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The Effect of Probiotics on Infections in Toddlers

This study has been completed.
Sponsor:
Collaborators:
Holbaek Sygehus
Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK
Chr Hansen A/S
Ferrosan A/S
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00823056
First received: January 14, 2009
Last updated: April 22, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diarrhoea
Respiratory Diseases
 Dietary Supplement: probiotics
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Probiotics on Infections in Toddlers

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • fewer infections [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • growth [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 454
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Dietary Supplement: probiotics
placebo
Active Comparator: 2 Dietary Supplement: probiotics
0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months

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.

  Eligibility

Ages Eligible for Study:   6 Months to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823056

Locations
Denmark
Paediatr. Depart., University Hospital Holbaek, University of Copenhagen
Holbaek, Region Zealand, Denmark, 4300
Sponsors and Collaborators
Roskilde County Hospital
Holbaek Sygehus
Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK
Chr Hansen A/S
Ferrosan A/S
Investigators
Principal Investigator: Mette L. Gyhrs, MD. ph.d student
  More Information

No publications provided

Responsible Party: Ms. Mette Louise Gyhrs, MD., Paediatr. Depart., Uni. Hosp. Holbaek, Region Zealand,DK, Uni. of CPH
ClinicalTrials.gov Identifier: NCT00823056     History of Changes
Other Study ID Numbers: Version 2
Study First Received: January 14, 2009
Last Updated: April 22, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Roskilde County Hospital:
Probiotics
Infections
Children

Additional relevant MeSH terms:
Diarrhea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013