Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Number of days absent from daycare due to respiratory and gastrointestinal infections
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Months to 14 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Probiotic (2 * 10^9 cfu/d)
Daily intake of bifidobacterium animalis ssp. Lactis (BB12) and Lactobacillus Rhamnosus GG (LGG) in a dosage of 10^9 cfu/day of each strain. The probiotics are provided as powder in a sachet, and can be added to food or drink
Intervention: Probiotic (2 * 10^9 cfu/day) (Dietary Supplement)
Placebo
provided as powder in a sachet, and can be added to food or drink
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Number of days absent from daycare due to respiratory and gastrointestinal infections
Time Frame: up to 6 month
Recorded weekly by the parents using web-based questionnaires
Secondary Outcomes
- Allergies(Up to 6 month)
- Gastrointestinal infections(Up to 6 month)
- Acute upper respiratory tract infections(Up to 6 month)
- Medical visits(Up to 6 month)
- Fever(Up to 6 month)
- Antibiotic use(Up to 6 month)
- Absence from day care due to illness other than infections(Up to 6 month)
- Acute lower respiratory infections(Up to 6 month)
- Parental absence from work due to illness of the child(Up to 6 month)
- Change from baseline in Thymus size(At baseline and after 6 mo (end of intervention))
Investigators
Arne Astrup
Professor
University of Copenhagen