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

Not Applicable

Completed

• Conditions: Children's Health and Growth; Childcare Absenteeism
• Interventions: Other: Yogurt drink with probiotic bacteria BB12; Other: Placebo

• Registration Number: NCT00653705
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Study Completion: 2009-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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.

Read More

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.)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Yogurt drink with probiotic bacteria BB12	Children given probiotic BB12 enriched yogurt drink.
Control	Placebo	Children given dairy drink.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill, School of Public Health; 🇺🇸 Chapel Hill, North Carolina, United States