Effect of Probiotic Supplementation on Immune Function in Healthy Infants (ProBoost)
|ClinicalTrials.gov Identifier: NCT01542320|
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Dietary Supplement: Lactobacillus reuteri DSM 17938 Other: Placebo||Not Applicable|
PROBLEM OF INTEREST: Lactic acid bacteria known as probiotics have been given to children and adults to prevent and treat gastrointestinal infections and to maintain intestinal health. This pilot study will collect information (biomarkers) of inflammation and immune response from healthy infants.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Application of Therapeutic Microbiology to Improve Immunogenicity|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Lactobacillus reuteri DSM 17938
Dietary Supplement: 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.
Other Name: BioGaia infant drops
Placebo Comparator: Placebo
Solution without the active probiotic Lactobacillus reuteri
Solution without active Lactobacillus reuteri
Other Name: Inactive solution
- Biomarkers of immune response [ Time Frame: Between 18 and 32 weeks of age ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542320
|United States, Georgia|
|Emory Children's Center|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Andi L Shane, MD, MPH, MSc||Emory University|