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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Investigate the Potential of Probiotics in Yogurt

NCT00492583

Healthy

COMPLETED PHASE3

Yogurt Study in Children 2-4 Years Old Attending Daycare

NCT00760851

Infections, Respiratory Diarrhea

COMPLETED PHASE3

Efficacy of Yogurt Containing BB12 in Subjects With GI Symptoms

NCT00618488

Pain

COMPLETED NA

Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

NCT01652287

Children

COMPLETED PHASE1

Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms

NCT01004484

Non-diarrhea Functional Bowel Symptoms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children's Health and Growth Childcare Absenteeism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic

Children given probiotic BB12 enriched yogurt drink.

Group Type ACTIVE_COMPARATOR

Yogurt drink with probiotic bacteria BB12

Intervention Type OTHER

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

Control

Children given dairy drink.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yogurt drink with probiotic bacteria BB12

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)

Minimum Eligible Age

12 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes