Effect of Probiotic Supplementation on Immune Function in Healthy Infants
NCT ID: NCT01542320
Last Updated: 2015-03-06
Study Results
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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COMPLETED
NA
15 participants
INTERVENTIONAL
2012-03-31
2014-12-31
Brief Summary
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Detailed Description
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HOW THE PROBLEM WILL BE STUDIED: The investigators will give an active Lactobacillus-containing probiotic or an inactive placebo without Lactobacillus to 38 healthy infants in the metropolitan Atlanta area from 2 weeks before until 2 weeks after they complete their rotavirus vaccine series. Half will be assigned to receive the active probiotic, half to receive the placebo. Neither the investigators nor the parent/ guardian of the study subject will know whether their infant is receiving the probiotic or placebo. A teaspoon of blood and a stool sample will be collected from each infant before they start taking the active probiotic or placebo and 2 weeks after they complete their rotavirus vaccine series. Each infant will receive the probiotic or placebo product for 2 weeks before starting their rotavirus vaccine series until 2 weeks after they complete their rotavirus vaccine series. The blood and stool samples will be examined for levels of inflammatory markers and measures of immune response. The stool samples may be stored for the later study of probiotic bacteria as well as for other bacteria and viruses. These results will help to determine if this Lactobacillus containing probiotic has an effect on immune response and inflammation in healthy infants.
HOW RESEARCH WILL ADVANCE SCIENTIFIC KNOWLEDGE AND HUMAN HEALTH: This study will provide new information about the impact of giving a Lactobacillus-containing probiotic supplement to healthy infants. CURRENT STANDARD OF CARE: The current standard of care is for infants to receive a probiotic at the discretion of their caregiver. By studying probiotic administration in a controlled way with a fixed dose schedule and a well categorized probiotic, and measuring blood and stool markers, the investigators hope to better understand the impact of a probiotic on immune response and inflammation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Probiotic
Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM 17938
1 x 10e8 colony forming units in 5 drops (0.17ml)daily from study enrollment to study conclusion. Duration based on rotavirus vaccine administration.
Placebo
Solution without the active probiotic Lactobacillus reuteri
Placebo
Solution without active Lactobacillus reuteri
Interventions
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Lactobacillus reuteri DSM 17938
1 x 10e8 colony forming units in 5 drops (0.17ml)daily from study enrollment to study conclusion. Duration based on rotavirus vaccine administration.
Placebo
Solution without active Lactobacillus reuteri
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for rotavirus immunization series
* No recognized immunodeficiency
* Ability to comply with study procedures
Exclusion Criteria
* Recognized immunodeficiency
* Inability to comply with study procedures
6 Weeks
32 Weeks
ALL
Yes
Sponsors
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The Gerber Foundation
OTHER
Emory University
OTHER
Responsible Party
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Andi L. Shane, MD
Assistant Professor of Pediatrics
Principal Investigators
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Andi L Shane, MD, MPH, MSc
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory Children's Center
Atlanta, Georgia, United States
Countries
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Other Identifiers
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ProBoost
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00055040
Identifier Type: -
Identifier Source: org_study_id
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