NCT00823056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

2.9 years

First QC Date

January 14, 2009

Last Update Submit

April 22, 2012

Conditions

DiarrhoeaRespiratory Diseases

Keywords

ProbioticsInfectionsChildren

Outcome Measures

Primary Outcomes (1)

  • fewer infections

    9 months

Secondary Outcomes (1)

  • growth

    9 months

Study Arms (2)

1

PLACEBO COMPARATOR
Dietary Supplement: probiotics

2

ACTIVE COMPARATOR
Dietary Supplement: probiotics

Interventions

probioticsDIETARY_SUPPLEMENT

placebo

1

Eligibility Criteria

Age6 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Holbæk, Region Sjælland, 4300, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23602437DERIVED

MeSH Terms

Conditions

DiarrheaRespiratory Tract DiseasesInfections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mette L. Gyhrs, MD.

    ph.d student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

DK(1)