Clinical trial NCT02180581: Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare
Official title: Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Days Absent From Daycare
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: 2014-07-02
Enrollment: 290
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
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 a combination of the two bacterial strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic manifestations in small children, and how a combination of BB-12 and LGG affects the immune system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.


Eligibility criteria: Inclusion Criteria:

* Expected to start daycare between the age of 8-14 month
* Intervention start 0 days to 12 weeks before starting daycare
* Expected to start daycare from september to february (both month included)
* Single born

Exclusion Criteria:

* 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 daycare 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:
citation: Schmidt RM, Pilmann Laursen R, Bruun S, Larnkjaer A, Molgaard C, Michaelsen KF, Host A. Probiotics in late infancy reduce the incidence of eczema: A randomized controlled trial. Pediatr Allergy Immunol. 2019 May;30(3):335-340. doi: 10.1111/pai.13018. Epub 2019 Feb 21.
citation: Laursen MF, Laursen RP, Larnkjaer A, Michaelsen KF, Bahl MI, Licht TR. Administration of two probiotic strains during early childhood does not affect the endogenous gut microbiota composition despite probiotic proliferation. BMC Microbiol. 2017 Aug 17;17(1):175. doi: 10.1186/s12866-017-1090-7.