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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Childcare Absenteeism
Children's Health and Growth

Treatments

Other: Placebo
Other: Yogurt drink with probiotic bacteria BB12

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00653705
06-0901

Details and patient eligibility

About

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.

Enrollment

181 patients

Sex

All

Ages

12 to 48 months old

Volunteers

Accepts Healthy Volunteers

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

  • 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.)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

181 participants in 2 patient groups, including a placebo group

Probiotic
Active Comparator group
Description:
Children given probiotic BB12 enriched yogurt drink.
Treatment:
Other: Yogurt drink with probiotic bacteria BB12
Control
Placebo Comparator group
Description:
Children given dairy drink.
Treatment:
Other: Placebo

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems