Impact of Probiotic Use on Immune Cell Function in Children
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/30/2019 |
| Start Date: | May 15, 2017 |
| End Date: | March 8, 2019 |
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
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
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
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).
We found this trial at
2
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