Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare
NCT ID: NCT02180581
Last Updated: 2016-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
290 participants
INTERVENTIONAL
2014-08-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
Probiotic (2 * 10^9 cfu/day)
Combination of two probiotics (2 \* 10\^9 cfu/day) or probiotics for 6 months
Placebo
provided as powder in a sachet, and can be added to food or drink
Placebo
Placebo for 6 months
Interventions
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Probiotic (2 * 10^9 cfu/day)
Combination of two probiotics (2 \* 10\^9 cfu/day) or probiotics for 6 months
Placebo
Placebo for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Months
14 Months
ALL
Yes
Sponsors
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The Danish Council for Strategic Research
OTHER
Chr Hansen
INDUSTRY
Technical University of Denmark
OTHER
University of Bergen
OTHER
Odense University Hospital
OTHER
Statens Serum Institut
OTHER
University of Copenhagen
OTHER
Responsible Party
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Arne Astrup
Professor
Locations
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Section of Paediatric and International Nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen
Frederiksberg, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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H-4-2014-032
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-4-2014-032
Identifier Type: -
Identifier Source: org_study_id
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