The Effect of Probiotics on Infections in Toddlers

This study is currently recruiting participants.

Verified by Roskilde County Hospital, March 2009

First Received: January 14, 2009 Last Updated: March 16, 2009 History of Changes

Sponsors and Collaborators:	Roskilde County Hospital Paediatr.Dept.University Hospital Holbaek,Hospital North,Region Zealand,DK Christian Hansen A/S Ferrosan A/S
Information provided by:	Roskilde County Hospital
ClinicalTrials.gov Identifier:	NCT00823056

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Probiotics on Infections in Toddlers

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Dietary Supplements Diets

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 ]

Estimated Enrollment:	440
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Dietary Supplement: probiotics placebo
2: Active Comparator	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

Contacts

Contact: Mette L. Gyhrs, MD.	+ 45 28228767	mlgy@regionsjaelland.dk
Contact: Henrik A. Verder, Prof., DMSci	+45 59484201	hav@regionsjaelland.dk

Locations

Denmark, Region Zealand
Paediatr. Depart., University Hospital Holbaek, University of Copenhagen	Recruiting
Holbaek, Region Zealand, Denmark, 4300
Contact: Mette L. Gyhrs, M.D. +45 28228767 mlgy@regionsjaelland.dk
Contact: Henrik A. Verder, M.D. , DMsci. +45 59484200 hav@regionsjaelland.dk
Principal Investigator: Mette L. Gyhrs, MD.

Sponsors and Collaborators

Roskilde County Hospital

Paediatr.Dept.University Hospital Holbaek,Hospital North,Region Zealand,DK

Christian Hansen A/S

Ferrosan A/S

Investigators

Principal Investigator:

Mette L. Gyhrs, MD.

ph.d student

More Information

No publications provided

Responsible Party:	Paediatr. Depart., Uni. Hosp. Holbaek, Region Zealand,DK, Uni. of CPH ( Ms. Mette Louise Gyhrs, MD. )
Study ID Numbers:	Version 2
Study First Received:	January 14, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00823056 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by Roskilde County Hospital:

Probiotics
Infections
Children

Study placed in the following topic categories:

Diarrhea
Respiratory Tract Diseases
Respiration Disorders

Additional relevant MeSH terms:

Respiratory Tract Diseases
Respiration Disorders
Infection

ClinicalTrials.gov processed this record on September 01, 2009