Infections, RespiratoryPhase 3SIPPY IINCT00760851
Yogurt Study in Children 2-4 Years Old Attending Daycare
A Phase 3 study testing probiotic strain Bb-12 and no Bb-12 in people with Infections, Respiratory and Diarrhea, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Respiratory, Diarrhea
- What is being tested?
- probiotic strain Bb-12 and no Bb-12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2010
- Phase
- Phase 3
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged 2 to 4 years of age
- Child attends daycare at least 3 days per week
Who cannot join
- Caregiver does not speak English or Spanish
- Caregiver does not agree to have their child refrain from cultured dairy products (yogurt) for the 105-day duration of the study
- Caregiver does not agree to collect a stool sample from their child on Day 0, 45, and 105 of the study
- Caregiver does not have a refrigerator to store the yogurt product at home
- Child is currently receiving breast milk
- Child has an allergy or hypersensitivity to milk proteins or other dairy food components such as lactose
Show all 13Show fewer
- Child has an allergy or hypersensitivity to strawberry or red food coloring
- Child has a chronic disease
- Child has had an infection or been sick 7 days prior to starting study
- Child has had diarrhea or constipation 7 days prior to starting study
- Child has a special diet as prescribed by a medical professional
- Child has received antibiotics, antiseptics, antifungal, corticosteroids, anti-histamines, non steroidal anti-inflammatory drugs within 7 days prior to starting the study
- Child has a congenital anomaly or birth defect that requires medical care
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Department of Family Medicine, Research Division
Washington D.C., District of Columbia, 20009
About this study
Official title: Study to Investigate the Potential of Probiotics II
The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare.
In this study, participants will be asked to:
- Give their child 4 oz. of the test yogurt each day for 90 days
- Keep a daily diary of their child's health
- Collect 3 stool samples from their child at the start, middle, and end of the study
- Speak with research personnel on a bi-weekly basis regarding their child's health
- Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study
- Conditions
- Infections, Respiratory, Diarrhea
- Being tested
- probiotic strain Bb-12, no Bb-12
- Keywords
- Probiotics, Child, preschool, Child Day Care Centers, Health, Immune system
- Medical subject headings
- Respiratory Tract Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic strain Bb-12Other
Also called Bifidobacterium lactis 12
10^9 CFU Bb-12 per 4 oz yogurt
no Bb-12Other
yogurt identical to intervention yogurt, only without Bb-12 added.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bb-12 supplemented strawberry yogurt drink Receives: Other: probiotic strain Bb-12 |
| 2 | Placebo comparator | Regular strawberry yogurt drink with no Bb-12 added Receives: Other: no Bb-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness
Measured: 90 days
Secondary outcomes (1)
Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school
Measured: 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, RespiratoryStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Penn State University
- Investigators
- Daniel Merenstein, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760851
- Sponsor's protocol ID
- 2008-01852
- Other IDs
- 2008
- Acronym
- SIPPY II
- Status last verified
- Feb 2011
- First submitted
- 24 Sep 2008
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Potential of Probiotics II
- ClinicalTrials.gov ID
- NCT00760851
- Acronym / sponsor ID
- SIPPY II / 2008-01852
- Conditions
- Infections, Respiratory, Diarrhea
- Keywords
- Probiotics, Child, preschool, Child Day Care Centers, Health, Immune system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Penn State University
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Sep 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 purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare.
In this study, participants will be asked to:
- Give their child 4 oz. of the test yogurt each day for 90 days
- Keep a daily diary of their child's health
- Collect 3 stool samples from their child at the start, middle, and end of the study
- Speak with research personnel on a bi-weekly basis regarding their child's health
- Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study
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 |
|---|---|---|
| 1 | Experimental | Other: probiotic strain Bb-12Bb-12 supplemented strawberry yogurt drink |
| 2 | Placebo comparator | Other: no Bb-12Regular strawberry yogurt drink with no Bb-12 added |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child aged 2 to 4 years of age
- Child attends daycare at least 3 days per week
Key exclusion criteria (13 listed)
- Caregiver does not speak English or Spanish
- Caregiver does not agree to have their child refrain from cultured dairy products (yogurt) for the 105-day duration of the study
- Caregiver does not agree to collect a stool sample from their child on Day 0, 45, and 105 of the study
- Caregiver does not have a refrigerator to store the yogurt product at home
- Child is currently receiving breast milk
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 |
|---|---|---|
| probiotic strain Bb-12Also: Bifidobacterium lactis 1210^9 CFU Bb-12 per 4 oz yogurt | Other | 1 |
| no Bb-12yogurt identical to intervention yogurt, only without Bb-12 added. | Other | 2 |
Primary outcome
To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness
Time frame: 90 days
1 secondary outcome
Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school
Time frame: 90
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 18 Mar 2011.
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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.
Daniel Merenstein, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing probiotic strain Bb-12 and no Bb-12 in people with Infections, Respiratory and Diarrhea, run by Georgetown University 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 2 inclusion and 13 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 18 Mar 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2011.