Impact of Probiotic Use on Immune Cell Function in Children
NCT ID: NCT02687503
Last Updated: 2019-12-24
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
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
23 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-05-15
Study Completion Date
2019-03-08
Brief Summary
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Probiotics are microorganisms that are believed to provide health benefits when consumed. The term probiotic is currently used to name ingested microorganisms associated with beneficial effects to humans and animals. Probiotics are popularized in the lay literature for many different clinical problems. They have been studied in infants and children as a preventive or treatment for a variety of infections. Studies on the medical benefits of probiotics have yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be conclusively proven for most of the studies conducted thus far. The putative benefit of probiotics in the prevention of infection relates to potential benefits to the innate and adaptive immune systems of infants.
The goals of this investigation are to study immune system cell function and microbiome in children who are taking probiotics.
To accomplish this goal, we propose a pilot study for which we will obtain blood and nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12 months-36 months over a 27-38 day period
The goals of this investigation are to study immune system cell function and microbiome in children who are taking probiotics.
To accomplish this goal, we propose a pilot study for which we will obtain blood and nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12 months-36 months over a 27-38 day period
Detailed Description
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Conditions
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Respiratory Tract Infections
Keywords
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Immune system
Probiotics
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Daily dose of probiotic
All children enrolled into the study will receive a daily dose of probiotic
Group Type
OTHER
Probiotic
Intervention Type
DIETARY_SUPPLEMENT
All children will receive a daily dose of probiotic (10⁹ cfu of L.acidophilus NCFM and B. lactis, Bi-07), a commercially available probiotic. Parents will give probiotic in 1 ounce of milk or water once a day for 30 days in an open label fashion.
Interventions
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Probiotic
All children will receive a daily dose of probiotic (10⁹ cfu of L.acidophilus NCFM and B. lactis, Bi-07), a commercially available probiotic. Parents will give probiotic in 1 ounce of milk or water once a day for 30 days in an open label fashion.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* Healthy children greater than 12 months-36 months of age
* English speaking parent
* Child has not received a live vaccine such as MMR or Varicella in the past 2 weeks
* English speaking parent
* Child has not received a live vaccine such as MMR or Varicella in the past 2 weeks
Exclusion Criteria
* Asthma/allergic rhinitis
* Premature birth (\< 36 weeks gestation)
* Known to be lactose intolerant
* Immunodeficiency or any underlying problem requiring the use of steroids or other immunosuppressive agents
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen in the last 2 weeks
* Currently taking probiotics, have received probiotics in the previous two weeks or are unwilling to refrain from the use of non-study probiotics during the next 30 days
* Any antibiotic treatment in the last 2 weeks
* Conditions which might interfere with dispersion of the probiotic after oral administration such as short gut or anomalies of the digestive tract
* Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Premature birth (\< 36 weeks gestation)
* Known to be lactose intolerant
* Immunodeficiency or any underlying problem requiring the use of steroids or other immunosuppressive agents
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen in the last 2 weeks
* Currently taking probiotics, have received probiotics in the previous two weeks or are unwilling to refrain from the use of non-study probiotics during the next 30 days
* Any antibiotic treatment in the last 2 weeks
* Conditions which might interfere with dispersion of the probiotic after oral administration such as short gut or anomalies of the digestive tract
* Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Minimum Eligible Age
12 Months
Maximum Eligible Age
36 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Danisco
INDUSTRY
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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UW Health 20 S. Park Clinic
Madison, Wisconsin, United States
Site Status
UW Health West Towne Clinic
Madison, Wisconsin, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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A536700
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\PEDIATRICS\PEDIATRICS
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0884
Identifier Type: -
Identifier Source: org_study_id