The Effect of Probiotics on Infections in Toddlers | NCT00823056

Studies
The Effect of Probiotics on Infections in Toddlers

NCT00823056

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Apr 24, 2012Estimated

Enrollment

454Actual

Phase

Phase 3

Conditions

Diarrhoea
Respiratory Diseases

Interventions

probiotics
probiotics

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jan 14, 2009

First Submission Date that Met QC Criteria

Jan 14, 2009

First Posted Date

Jan 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2012

Last Update Posted Date

Apr 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Zealand University HospitalOTHER

Collaborators

Name	Class
Holbaek Sygehus	OTHER
Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK	UNKNOWN
Novonesis	INDUSTRY
Ferrosan AS

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

454Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Dietary Supplement: probiotics
2	Active Comparator		Dietary Supplement: probiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotics	Dietary Supplement	placebo	1
probiotics

Measure	Description	Time Frame
fewer infections		9 months

Measure	Description	Time Frame
growth		9 months

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

7 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette L. Gyhrs, MD.	ph.d student	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Paediatr. Depart., University Hospital Holbaek, University of Copenhagen		Holbæk	Region Sjælland	4300	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23602437	Derived	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.

ID	Term
D003967	Diarrhea
D012140	Respiratory Tract Diseases
D007239	Infections

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena