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

Not Applicable

Terminated

• Conditions: Respiratory Tract Infections; Gastrointestinal Infections; Allergy; Days Absent From Day Care
• Interventions: Dietary Supplement: Probiotic (10^9 CFU/day); Other: Placebo; Dietary Supplement: Probiotic (10^8 CFU/day)

• Registration Number: NCT02032056
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic (10^9 cfu/day)	Probiotic (10^9 CFU/day)	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.
Placebo	Placebo	provided as powder in a sachet which can be added to food or drink.
probiotic (10^8 cfu/day)	Probiotic (10^8 CFU/day)	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.

Primary Outcome Measures

Name	Time	Method
Number of days absent from day care due to respiratory and gastrointestinal infections	Up to 6 month	Recorded weekly by the parents using web-based questionnaires

Secondary Outcome Measures

Name	Time	Method
Acute lower respiratory infections	Up to 6 month	Number of children with at least 1 episode of a lower respiratory tract infection (LRTI).; LRTI include bronchitis and pneumonia; Recorded by the parents weekly using web-based questionnaires.
Acute upper respiratory tract infections	Up to 6 month	Number of days with acute upper respiratory tract infections (URTI); Number of children with at least 1 episode of URTI; Number of children with at least 3 episodes of URTI; Number of URTI episodes/child/year; Duration of URTI episodes (days); Additionally,symptoms of cold (defined as 2 days with runny/stuffy nose or cough); Recorded by the parents daily/weekly using web-based questionnaires.
Gastrointestinal infections	Up to 6 month	Number of children with at least 1 episode of diarrhea; Duration of episodes with diarrhea(days); Number of episodes/child/year with diarrhea; Number of days with vomiting.; Recorded by the parents daily using web-based questionnaires
Fever	Up to 6 month	Number of days with fever; Recorded by the parents using web-based questionnaires
Antibiotic use	Up to 6 month	Number of treatments with antibiotics during the intervention period; Recorded weekly by the parents using web-based questionnires
Allergies	Up to 6 month	Number of children developing allergies during the intervention period (asthma, allergic rhinitis, atopic dermatitis, food allergies); Age for diagnosis of allergies; Use of medication due to allergies.; Recorded by the parents monthly using web-based questionnaires
Absence from day care due to illness other than infections	Up to 6 month	Number of days the child is absent from day care due to illness, which is not due to infections.; Recorded by the parents weekly using web-based questionnaires
Parental absence from work due to illness of the child	Up to 6 month	Number of days a parent is absent from work due to illness of the child (infections and other illnesses, respectively); Recorded by the parents weekly using web-based questionnaires
Medical visits	Up to 6 month	Number of visits to a doctor due to infections and other illnesses, respectively.; Recorded by the parents using web-based questionnaires
Change from baseline in Thymus size	At baseline and after 6 mo (end of intervention)	Change in thymic size during intervention period will be evaluated using ultraound

Trial Locations

Locations (1)

Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen; 🇩🇰 Frederiksberg, Denmark