Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare (ProbiComp)

University of Copenhagen

Status: Completed

Conditions: Days Absent From Daycare; Respiratory Tract Infections; Allergy; Gastrointestinal Infections

Treatments: Dietary Supplement: Probiotic (2 * 10^9 cfu/day); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02180581

H-4-2014-032 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 8 to 14 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups, including a placebo group

Probiotic (2 * 10^9 cfu/d)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic (2 * 10^9 cfu/day)

Placebo

Placebo Comparator group

Description:

provided as powder in a sachet, and can be added to food or drink

Treatment:

Dietary Supplement: Placebo