Children's Health and GrowthNCT00653705
The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
A study testing Yogurt drink with probiotic bacteria BB12 in people with Children's Health and Growth and Childcare Absenteeism, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Children's Health and Growth, Childcare Absenteeism
- What is being tested?
- Yogurt drink with probiotic bacteria BB12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, School of Public Health
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism
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.
- Being tested
- Yogurt drink with probiotic bacteria BB12, Placebo
- Keywords
- Probiotics, Children, Child Care Center, Nutrition, Health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt drink with probiotic bacteria BB12Other
Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
PlaceboOther
Vanilla flavored dairy drink. One bottle a day for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Children given probiotic BB12 enriched yogurt drink. Receives: Other: Yogurt drink with probiotic bacteria BB12 |
| Control | Placebo comparator | Children given dairy drink. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionApr 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children's Health and GrowthStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Principal investigator, Tamar Ringel-Kulka, MPH, University of North Carolina, Chapel Hill
- Investigators
- Tamar Ringel-Kulka, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653705
- Sponsor's protocol ID
- 06-0901
- Status last verified
- May 2013
- First submitted
- 1 Apr 2008
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism
- ClinicalTrials.gov ID
- NCT00653705
- Acronym / sponsor ID
- 06-0901
- Keywords
- Probiotics, Children, Child Care Center, Nutrition, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Jan 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Other: Yogurt drink with probiotic bacteria BB12Children given probiotic BB12 enriched yogurt drink. |
| Control | Placebo comparator | Other: PlaceboChildren given dairy drink. |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt drink with probiotic bacteria BB12Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks. | Other | Probiotic |
| PlaceboVanilla flavored dairy drink. One bottle a day for 16 weeks. | Other | Control |
Primary outcome
Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
Time frame: 16 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Derived from this study: PubMed 25841539Ringel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamar Ringel-Kulka, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt drink with probiotic bacteria BB12 in people with Children's Health and Growth and Childcare Absenteeism, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00653705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.