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

Primary Purpose

Days Absent From Daycare, Respiratory Tract Infections, Gastrointestinal Infections

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Probiotic (2 * 10^9 cfu/day)

Placebo

About this trial

This is an interventional prevention trial for Days Absent From Daycare focused on measuring Infections, Allergy, Immune function, Microbiota, Infant

Eligibility Criteria

8 Months - 14 Months (Child)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic (2 * 10^9 cfu/d)

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Number of days absent from daycare due to respiratory and gastrointestinal infections

Recorded weekly by the parents using web-based questionnaires

Secondary Outcome Measures

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.

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.

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

Fever

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

Antibiotic use

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

Allergies

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 using web-based questionnaires

Absence from day care due to illness other than infections

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

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

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

Change in thymic size during intervention period will be evaluated using ultrasound

Full Information

NCT ID

NCT02180581

First Posted

June 30, 2014

Last Updated

August 23, 2016

Sponsor

University of Copenhagen

Collaborators

The Danish Council for Strategic Research, Chr Hansen, Technical University of Denmark, University of Bergen, Odense University Hospital, Statens Serum Institut

1. Study Identification

Unique Protocol Identification Number

NCT02180581

Brief Title

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

Acronym

ProbiComp

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Copenhagen

Collaborators

The Danish Council for Strategic Research, Chr Hansen, Technical University of Denmark, University of Bergen, Odense University Hospital, Statens Serum Institut

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Days Absent From Daycare, Respiratory Tract Infections, Gastrointestinal Infections, Allergy

Keywords

Infections, Allergy, Immune function, Microbiota, Infant

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic (2 * 10^9 cfu/d)

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic (2 * 10^9 cfu/day)

Other Intervention Name(s)

bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, Lactobacillus Rhamnosus GG (LGG), 10^9 cfu/day

Intervention Description

Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo for 6 months

Primary Outcome Measure Information:

Title

Number of days absent from daycare due to respiratory and gastrointestinal infections

Description

Recorded weekly by the parents using web-based questionnaires

Time Frame

up to 6 month

Secondary Outcome Measure Information:

Title

Acute upper respiratory tract infections

Description

Time Frame

Up to 6 month

Title

Acute lower respiratory infections

Description

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

Title

Gastrointestinal infections

Description

Time Frame

Up to 6 month

Title

Fever

Description

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

Time Frame

Up to 6 month

Title

Antibiotic use

Description

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

Time Frame

Up to 6 month

Title

Allergies

Description

Time Frame

Up to 6 month

Title

Absence from day care due to illness other than infections

Description

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

Time Frame

Up to 6 month

Title

Parental absence from work due to illness of the child

Description

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

Time Frame

Up to 6 month

Title

Medical visits

Description

Number of visits to a doctor due to infections and other illnesses, respectively. Recorded by the parents using web-based questionnaires

Time Frame

Up to 6 month

Title

Change from baseline in Thymus size

Description

Change in thymic size during intervention period will be evaluated using ultrasound

Time Frame

At baseline and after 6 mo (end of intervention)

Other Pre-specified Outcome Measures:

Title

Change from baseline in biological markers for the immune system

Description

Analysis of biological material investigating the effect on the immune system by biological markers .

Time Frame

At baseline and after 6 mo

Title

Change from baseline in biological markers for gastro-intestinal tract

Description

Analysis of biological material investigating the effect on the gastrointestinal tract.

Time Frame

At baseline and after 6 mo

Title

Change from baseline in Biological markers of allergy

Description

analysis of biological samples investigating the effect on allergy by biological markers at baseline and at 6 mo

Time Frame

At baseline and after 6 mo

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Months

Maximum Age & Unit of Time

14 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Frederiksberg

ZIP/Postal Code

1958

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

30790361

Citation

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.

Results Reference

derived

PubMed Identifier

28818050

Citation

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.

Results Reference

derived

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

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