NCT00653705

Brief Summary

The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

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

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

April 1, 2008

Last Update Submit

May 30, 2013

Conditions

Children's Health and GrowthChildcare Absenteeism

Keywords

ProbioticsChildrenChild Care CenterNutritionHealth promotion

Outcome Measures

Primary Outcomes (1)

  • Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism

    16 weeks

Secondary Outcomes (1)

  • Health care utilization and illness related costs as measured by number of physician visits, ER visits, hospitalizations, and antibiotics use. Also, child growth and quality of life. Exploratory biomarker outcomes in stool.

    16 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Children given probiotic BB12 enriched yogurt drink.

Other: Yogurt drink with probiotic bacteria BB12

Control

PLACEBO COMPARATOR

Children given dairy drink.

Other: Placebo

Interventions

Yogurt drink with probiotic bacteria BB12OTHER

Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.

Probiotic
PlaceboOTHER

Vanilla flavored dairy drink. One bottle a day for 16 weeks.

Control

Eligibility Criteria

Age12 Months - 48 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • An informed consent has been signed by the parents.
  • The child is at least one year old and has not had his 4th birthday at the beginning of the study
  • The child is healthy.
  • The child attends child care center at least 5 days a week, \> 4 hours per day.

You may not qualify if:

  • Was born preterm.
  • Had a birth weight \<2,500 g.
  • Has congenital anomalies.
  • Has a structural abnormality of the digestive tract or previous significant gastrointestinal surgery.
  • Has chronic disease or malignancy.
  • Has a serious, unstable medical condition.
  • Is Failure to Thrive (FTT) (\<5th percentile of ideal body weight).
  • Has an allergy or atopic disease.
  • Has an allergy or intolerance to milk/dairy products.
  • Has an established diagnosis of lactase deficiency.
  • Is predisposed to infection (i.e., compromised immune system, HIV-AIDS, active bacterial disease, under steroid treatment).
  • Received antibiotic treatment or intentionally consumes probiotic products during the preceding 4 weeks. (If the subject was on antibiotics before the beginning of the study or probiotics, a washout period of 2 weeks is required.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill, School of Public Health

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Ringel-Kulka T, Kotch JB, Jensen ET, Savage E, Weber DJ. Randomized, double-blind, placebo-controlled study of synbiotic yogurt effect on the health of children. J Pediatr. 2015 Jun;166(6):1475-81.e1-3. doi: 10.1016/j.jpeds.2015.02.038. Epub 2015 Apr 1.

    PMID: 25841539DERIVED

Study Officials

  • Tamar Ringel-Kulka, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

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
Assistant Professor, Maternal and Child Health

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 7, 2008

Study Start

January 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

US(1)