Clinical trial NCT02032056: Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
Official title: The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Days Absent From Day Care
Respiratory Tract Infections
Gastrointestinal Infections
Allergy
Keywords: Infections
Allergy
Immune function
Microbiota
infant
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Council for Strategic Research
name: Chr Hansen
name: Technical University of Denmark
name: University of Bergen
name: Odense University Hospital
name: Statens Serum Institut
First posted: 2014-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.


Eligibility criteria: Inclusion Criteria:

* 9 - 12 1/2 month at intervention start
* Start in daycare 4 +/- 2 weeks after intervention start
* Single born

Exclusion Criteria:

* Children born before 37th gestational week
* Children with a birth weight \< 2500 g
* Children suffering from severe chronic illness
* Children receiving regular medication
* Children who have received antibiotics within a month before intervention start
* Children whose parents do not speak Danish

Primary outcomes:
measure: Number of days absent from day care due to respiratory and gastrointestinal infections
timeFrame: Up to 6 month
Secondary outcomes:
measure: Acute upper respiratory tract infections
timeFrame: Up to 6 month
measure: Acute lower respiratory infections
timeFrame: Up to 6 month
measure: Gastrointestinal infections
timeFrame: Up to 6 month
measure: Fever
timeFrame: Up to 6 month
measure: Antibiotic use
timeFrame: Up to 6 month
measure: Allergies
timeFrame: Up to 6 month
measure: Absence from day care due to illness other than infections
timeFrame: Up to 6 month
measure: Parental absence from work due to illness of the child
timeFrame: Up to 6 month
measure: Medical visits
timeFrame: Up to 6 month
measure: Change from baseline in Thymus size
timeFrame: At baseline and after 6 mo (end of intervention)
Other outcomes:
measure: Change from baseline in biological markers for the immune system
timeFrame: At baseline and after 6 mo
measure: Change from baseline in biological markers for gastro-intestinal tract
timeFrame: At baseline and after 6 mo
measure: Change from baseline in Biological markers of allergy
timeFrame: At baseline and after 6 mo
Locations:
city: Frederiksberg
country: Denmark
facility: Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen
Study officials:
References: