CompletedNCT00653705Updated May 31, 2013

The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism

An interventional study of Yogurt drink with probiotic bacteria BB12 and Placebo in Children's Health and Growth and Childcare Absenteeism, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 12 Months to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-31.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 181
Allocation: Randomized
Ages: 12 Months to 48 Months
Sex: All

Study 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.

Conditions studied

Children's Health and Growth
Childcare Absenteeism

Keywords

Probiotics
Children
Child Care Center
Nutrition
Health promotion

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Months to 48 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.)

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 181 participants (actual)

Study arms

Active comparator
Probiotic
Children given probiotic BB12 enriched yogurt drink.
Other: Yogurt drink with probiotic bacteria BB12
Placebo comparator
Control
Children given dairy drink.
Other: Placebo

Interventions

OtherYogurt drink with probiotic bacteria BB12
Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
OtherPlacebo
Vanilla flavored dairy drink. One bottle a day for 16 weeks.

What researchers measure

Primary outcomes

Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
Time frame: 16 weeks

Secondary outcomes

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.
Time frame: 16 weeks

Study locations

1 site

University of North Carolina at Chapel Hill, School of Public Health
Chapel Hill, North Carolina 27599, United States

References and documents

Publications

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. PubMed 25841539 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00653705
Lead sponsor: University of North Carolina, Chapel Hill
Collaborators: General Mills
Responsible party: Tamar Ringel-Kulka, MPH (Assistant Professor, Maternal and Child Health, University of North Carolina, Chapel Hill) — Principal investigator
First posted: Apr 7, 2008
Start date: Jan 2007
Primary completion: Apr 2008
Completion: Apr 2009
Last update: May 31, 2013

Study contacts

Tamar Ringel-Kulka, MD, MPH

principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of North Carolina, Chapel Hill

Start the discussion