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

NCT ID: NCT02032056

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Days Absent From Day Care Respiratory Tract Infections Gastrointestinal Infections Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Probiotic (10^9 CFU/day)

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

Probiotic (10^8 CFU/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Probiotic (10^9 CFU/day)

Intervention Type DIETARY_SUPPLEMENT

Probiotic (10^8 CFU/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Other Intervention Names

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Bifidobacterium animalis ssp. Lactis (BB12) Bifidobacterium animalis ssp. Lactis (BB12)

Eligibility Criteria

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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
Minimum Eligible Age

9 Months

Maximum Eligible Age

13 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Council for Strategic Research

OTHER

Sponsor Role collaborator

Chr Hansen

INDUSTRY

Sponsor Role collaborator

Technical University of Denmark

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Statens Serum Institut

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Arne Astrup

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-3-2013-064

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-3-2013-064

Identifier Type: -

Identifier Source: org_study_id

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