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The Effect of Probiotics on Infections in Toddlers

Primary Purpose

Diarrhoea, Respiratory Diseases

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
probiotics
probiotics
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhoea focused on measuring Probiotics, Infections, Children

Eligibility Criteria

6 Months - 7 Months (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Paediatr. Depart., University Hospital Holbaek, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

fewer infections

Secondary Outcome Measures

growth

Full Information

First Posted
January 14, 2009
Last Updated
April 22, 2012
Sponsor
Zealand University Hospital
Collaborators
Holbaek Sygehus, Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK, Chr Hansen, Ferrosan A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00823056
Brief Title
The Effect of Probiotics on Infections in Toddlers
Official Title
The Effect of Probiotics on Infections in Toddlers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea, Respiratory Diseases
Keywords
Probiotics, Infections, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months
Primary Outcome Measure Information:
Title
fewer infections
Time Frame
9 months
Secondary Outcome Measure Information:
Title
growth
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette L. Gyhrs, MD.
Organizational Affiliation
ph.d student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paediatr. Depart., University Hospital Holbaek, University of Copenhagen
City
Holbaek
State/Province
Region Zealand
ZIP/Postal Code
4300
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23602437
Citation
Nielsen AC, Gyhrs ML, Nielsen LP, Pedersen C, Bottiger B. Gastroenteritis and the novel picornaviruses aichi virus, cosavirus, saffold virus, and salivirus in young children. J Clin Virol. 2013 Jul;57(3):239-42. doi: 10.1016/j.jcv.2013.03.015. Epub 2013 Apr 19.
Results Reference
derived

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The Effect of Probiotics on Infections in Toddlers

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