NCT02032056

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

November 20, 2013

Last Update Submit

May 2, 2018

Conditions

Days Absent From Day CareRespiratory Tract InfectionsGastrointestinal InfectionsAllergy

Keywords

InfectionsAllergyImmune functionMicrobiotainfant

Outcome Measures

Primary Outcomes (1)

  • Number of days absent from day care 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 (3)

probiotic (10^9 cfu/day)

EXPERIMENTAL

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.

Dietary Supplement: Probiotic (10^9 CFU/day)

probiotic (10^8 cfu/day)

EXPERIMENTAL

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.

Dietary Supplement: Probiotic (10^8 CFU/day)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Probiotic (10^9 CFU/day)DIETARY_SUPPLEMENT
Also known as: Bifidobacterium animalis ssp. Lactis (BB12)
probiotic (10^9 cfu/day)
Probiotic (10^8 CFU/day)DIETARY_SUPPLEMENT
Also known as: Bifidobacterium animalis ssp. Lactis (BB12)
probiotic (10^8 cfu/day)
PlaceboOTHER
Placebo

Eligibility Criteria

Age9 Months - 13 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • /2 month at intervention start
  • Start in daycare 4 +/- 2 weeks after intervention start
  • 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

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

November 20, 2013

First Posted

January 9, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

DK(1)