Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period (ProbiComp)

University of Copenhagen

Status: Terminated

Conditions: Days Absent From Day Care; Respiratory Tract Infections; Allergy; Gastrointestinal Infections

Treatments: Dietary Supplement: Probiotic (10^8 CFU/day); Other: Placebo; Dietary Supplement: Probiotic (10^9 CFU/day)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02032056

H-3-2013-064 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 9 to 13 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups, including a placebo group

probiotic (10^9 cfu/day)

Experimental group

Description:

Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10\^9 cfu/day, provided as powder in a sachet which can be added to food or drink.

Treatment:

Dietary Supplement: Probiotic (10^9 CFU/day)

probiotic (10^8 cfu/day)

Experimental group

Description:

Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10\^8 cfu/day, provided as powder in a sachet which can be added to food or drink.

Treatment:

Dietary Supplement: Probiotic (10^8 CFU/day)

Placebo

Placebo Comparator group

Description:

provided as powder in a sachet which can be added to food or drink.

Treatment:

Other: Placebo