HealthyPhase 3SIPPYNCT00492583
Study to Investigate the Potential of Probiotics in Yogurt
A Phase 3 study testing Bifidobacterium lactis (BB-12) in people with Healthy, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bifidobacterium lactis (BB-12)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 1-3
- attending daycare or preschool centers at least 3 days a week
- male or female
- parents must speak English or Spanish
- subjects or parents/legal guardians who agree to have their child refrain from consuming any other yogurts or foods containing probiotics for the duration of the study
Who cannot join
- subjects with developmental delays
- subjects with chronic conditions such as diabetes or asthma that require daily medication
- subjects with birth weight <2500 grams
- subjects with strawberry allergies
- subjects with active diarrhea
- subjects with congenital anomalies
- subjects with failure to thrive
- subjects with parental belief of lactose intolerance
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Department of Family Medicine
Washington D.C., District of Columbia, 20007
About this study
The purpose of this study is to determine if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3.
Read the detailed description
It is reported that more than half of all young children attend daycare centers in the United States. Absences due to illnesses are costly both on an individual and societal level; these absences are generally due to diarrhea or upper respiratory infections.
In the U.S., children under five years of age experience 20-35 million episodes of diarrhea per year. These episodes lead to 2-3.5 million physician visits (which account for 10% of all visits by children), more than 200,000 hospitalizations (13% of hospital admissions in children under five years), and 325-425 deaths annually. In 1991, the outpatient costs of treating diarrhea in children under age three was calculated at 0.6-1 billion dollars per year.
Respiratory illness is among the leading causes of death in children under five years of age. Approximately 200,000 deaths in the U.S. and 3.9 million deaths worldwide are attributed to respiratory illnesses. Respiratory illness is also the most frequent reason for physician consultation, with more than 40% of all pediatric outpatient visits related to respiratory illness. According to a recent study, 39% of children attending daycare experienced acute otitis media (ear infection) and 26% reported allergies. Most notably, 10% of children attending daycare were admitted to the hospital due to respiratory illnesses.
We have chosen BB-12 as the probiotic for this study as it is one of the best characterized probiotics with a long safety record in children, a well-proven ability to colonize the human intestinal tract, and demonstrated efficacy for different pediatric conditions. Furthermore, BB-12 is a commercially available probiotic strain that has been used in a number of feeding and clinical trials.
In fact, there is a new infant formula on the market, using the identical strain we are, in the first commercially available probiotic infant formula available in the United States. Not only has BB-12 been found to survive transit through the stomach, small intestine and colon, but also long-term consumption of BB-12 formula at levels as high as 1 billion CFU/g (240 g serving) have been found to be safe.
Our overall goal is to demonstrate that a probiotic-containing yogurt beverage can be used successfully as a vehicle for delivering health-enhancing probiotics; more specifically to determine if a yogurt drink containing Bifidobacterium lactis BB-12 at a minimum 1010 colony forming units (CFU)/per serving can prevent daycare absences.
The rationale for focusing on food as a vehicle for the transmission of probiotics is that it has the potential to benefit children more than using probiotics in a more medicinal manner, such as pills or capsules. By providing an intervention in the form of a yogurt drink, parents are given a more convenient and simple alternative to traditional probiotic supplements. As yogurt is known to be a nutrient dense food, a yogurt drink is likely to be more appealing to both children and their parents for long-term consumption than pharmaceutical-like preparations. Although compliance with most medicinal regimens is around 50%, by offering a more attractive formulation of high dose probiotics and collaborating with participants we believe compliance will exceed normal levels. Ultimately, by capitalizing on the widely accepted healthy image of yogurt and offering a simple, convenient source of probiotics, we believe this product has the potential to positively impact the health of children around the world.
- Conditions
- Healthy
- Being tested
- Bifidobacterium lactis (BB-12), Placebo
- Keywords
- probiotic, health, bifidobacterium lactis, BB-12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium lactis (BB-12)Drug
The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin).
PlaceboDrug
The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink. Receives: Drug: Placebo |
| Bifidobacterium lactis (BB-12) | Experimental | Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink. Receives: Drug: Bifidobacterium lactis (BB-12) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Children Are Out of School Sick
Outcome measure, "number of days children are out of school sick" was measured for the entire population
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Investigators
- Daniel J Merenstein, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492583
- Sponsor's protocol ID
- 2007-273
- Acronym
- SIPPY
- Status last verified
- Jun 2011
- First submitted
- 25 Jun 2007
- Last updated
- 17 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Merenstein DJ, Smith KH, Scriven M, Roberts RF, Sanders ME, Petterson S. The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):685-91. doi: 10.1038/ejcn.2010.30. Epub 2010 Mar 10.
PubMed 20216564
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Potential of Probiotics in Yogurt
- ClinicalTrials.gov ID
- NCT00492583
- Acronym / sponsor ID
- SIPPY / 2007-273
- Conditions
- Healthy
- Keywords
- probiotic, health, bifidobacterium lactis, BB-12
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 17 Aug 2011
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 if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3.
Detailed description
It is reported that more than half of all young children attend daycare centers in the United States. Absences due to illnesses are costly both on an individual and societal level; these absences are generally due to diarrhea or upper respiratory infections.
In the U.S., children under five years of age experience 20-35 million episodes of diarrhea per year. These episodes lead to 2-3.5 million physician visits (which account for 10% of all visits by children), more than 200,000 hospitalizations (13% of hospital admissions in children under five years), and 325-425 deaths annually. In 1991, the outpatient costs of treating diarrhea in children under age three was calculated at 0.6-1 billion dollars per year.
Respiratory illness is among the leading causes of death in children under five years of age. Approximately 200,000 deaths in the U.S. and 3.9 million deaths worldwide are attributed to respiratory illnesses. Respiratory illness is also the most frequent reason for physician consultation, with more than 40% of all pediatric outpatient visits related to respiratory illness. According to a recent study, 39% of children attending daycare experienced acute otitis media (ear infection) and 26% reported allergies. Most notably, 10% of children attending daycare were admitted to the hospital due to respiratory illnesses.
We have chosen BB-12 as the probiotic for this study as it is one of the best characterized probiotics with a long safety record in children, a well-proven ability to colonize the human intestinal tract, and demonstrated efficacy for different pediatric conditions. Furthermore, BB-12 is a commercially available probiotic strain that has been used in a number of feeding and clinical trials.
In fact, there is a new infant formula on the market, using the identical strain we are, in the first commercially available probiotic infant formula available in the United States. Not only has BB-12 been found to survive transit through the stomach, small intestine and colon, but also long-term consumption of BB-12 formula at levels as high as 1 billion CFU/g (240 g serving) have been found to be safe.
Our overall goal is to demonstrate that a probiotic-containing yogurt beverage can be used successfully as a vehicle for delivering health-enhancing probiotics; more specifically to determine if a yogurt drink containing Bifidobacterium lactis BB-12 at a minimum 1010 colony forming units (CFU)/per serving can prevent daycare absences.
The rationale for focusing on food as a vehicle for the transmission of probiotics is that it has the potential to benefit children more than using probiotics in a more medicinal manner, such as pills or capsules. By providing an intervention in the form of a yogurt drink, parents are given a more convenient and simple alternative to traditional probiotic supplements. As yogurt is known to be a nutrient dense food, a yogurt drink is likely to be more appealing to both children and their parents for long-term consumption than pharmaceutical-like preparations. Although compliance with most medicinal regimens is around 50%, by offering a more attractive formulation of high dose probiotics and collaborating with participants we believe compliance will exceed normal levels. Ultimately, by capitalizing on the widely accepted healthy image of yogurt and offering a simple, convenient source of probiotics, we believe this product has the potential to positively impact the health of children around the world.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink. |
| Bifidobacterium lactis (BB-12) | Experimental | Drug: Bifidobacterium lactis (BB-12)Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- aged 1-3
- attending daycare or preschool centers at least 3 days a week
- male or female
- parents must speak English or Spanish
- subjects or parents/legal guardians who agree to have their child refrain from consuming any other yogurts or foods containing probiotics for the duration of the study
Key exclusion criteria (8 listed)
- subjects with developmental delays
- subjects with chronic conditions such as diabetes or asthma that require daily medication
- subjects with birth weight <2500 grams
- subjects with strawberry allergies
- subjects with active diarrhea
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 |
|---|---|---|
| Bifidobacterium lactis (BB-12)The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin). | Drug | Bifidobacterium lactis (BB-12) |
| PlaceboThe placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. | Drug | Placebo |
Primary outcome
Number of Days Children Are Out of School Sick
Time frame: 90 days
Outcome measure, "number of days children are out of school sick" was measured for the entire population
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20216564Merenstein DJ, Smith KH, Scriven M, Roberts RF, Sanders ME, Petterson S. The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):685-91. doi: 10.1038/ejcn.2010.30. Epub 2010 Mar 10.
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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 J 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 Bifidobacterium lactis (BB-12) in people with Healthy, 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 5 inclusion and 8 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 17 Aug 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?
Yes. Results are posted in the registry (first posted 17 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days Children Are Out of School Sick (time frame: 90 days). 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 NCT00492583, 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 17 Aug 2011.