NCT02180581

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

June 30, 2014

Last Update Submit

August 23, 2016

Conditions

Days Absent From DaycareRespiratory Tract InfectionsGastrointestinal InfectionsAllergy

Keywords

InfectionsAllergyImmune functionMicrobiotaInfant

Outcome Measures

Primary Outcomes (1)

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

    Recorded weekly by the parents using web-based questionnaires

    up to 6 month

Secondary Outcomes (10)

  • Acute upper respiratory tract infections

    Up to 6 month

  • Acute lower respiratory infections

    Up to 6 month

  • Gastrointestinal infections

    Up to 6 month

  • Fever

    Up to 6 month

  • Antibiotic use

    Up to 6 month

  • +5 more secondary outcomes

Other Outcomes (3)

  • Change from baseline in biological markers for the immune system

    At baseline and after 6 mo

  • Change from baseline in biological markers for gastro-intestinal tract

    At baseline and after 6 mo

  • Change from baseline in Biological markers of allergy

    At baseline and after 6 mo

Study Arms (2)

Probiotic (2 * 10^9 cfu/d)

EXPERIMENTAL

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

Dietary Supplement: Probiotic (2 * 10^9 cfu/day)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic (2 * 10^9 cfu/day)DIETARY_SUPPLEMENT

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

Also known as: bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, Lactobacillus Rhamnosus GG (LGG), 10^9 cfu/day
Probiotic (2 * 10^9 cfu/d)
PlaceboDIETARY_SUPPLEMENT

Placebo for 6 months

Placebo

Eligibility Criteria

Age8 Months - 14 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Frederiksberg, 1958, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 30790361DERIVED

  • 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.

    PMID: 28818050DERIVED

MeSH Terms

Conditions

Respiratory Tract InfectionsHypersensitivityInfections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 2, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

DK(1)