Effect of Probiotic Supplementation on Immune Function in Healthy Infants
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to understand how a probiotic might change the immune response
      of healthy infants.
    

Detailed description: 
      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.
    

Intervention name(s): Lactobacillus reuteri DSM 17938; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1 x 10e8 colony forming units in 5 drops (0.17ml)daily from study enrollment to study conclusion. Duration based on rotavirus vaccine administration.; Solution without active Lactobacillus reuteri
Other intervention name(s): BioGaia infant drops; Inactive solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: probiotic; Lactobacillus reuteri DSM 17938; healthy infants