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

N/ATerminatedNCT02032056

University of Copenhagen40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Days Absent From Day Care Respiratory Tract Infections Gastrointestinal Infections Allergy

Interventions

Probiotic (10^9 CFU/day)DIETARY_SUPPLEMENT

Probiotic (10^8 CFU/day)DIETARY_SUPPLEMENT

PlaceboOTHER

Eligibility

Sex: ALLMin age: 9 MonthsMax age: 13 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen

Frederiksberg, Denmark

Outcomes

Primary Outcomes

Number of days absent from day care due to respiratory and gastrointestinal infections

Recorded weekly by the parents using web-based questionnaires

Time frame: Up to 6 month

Secondary Outcomes

Acute upper respiratory tract infections

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.

Time frame: Up to 6 month

Acute lower respiratory infections

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.

Time frame: Up to 6 month

Gastrointestinal infections

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

Time frame: Up to 6 month

Fever

Number of days with fever Recorded by the parents using web-based questionnaires

Time frame: Up to 6 month

Antibiotic use

Number of treatments with antibiotics during the intervention period Recorded weekly by the parents using web-based questionnires

Time frame: Up to 6 month

Data from ClinicalTrials.gov

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