Effect of Probiotic Supplementation on Immune Function in Healthy Infants (ProBoost)

Application of Therapeutic Microbiology to Improve Immunogenicity

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

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri DSM 17938; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Children's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy infant
• Eligible for rotavirus immunization series
• No recognized immunodeficiency
• Ability to comply with study procedures

Exclusion Criteria:

• Ineligible for rotavirus immunization series
• Recognized immunodeficiency
• Inability to comply with study procedures

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; 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 Names: BioGaia infant drops
Placebo Comparator: Placebo; Solution without the active probiotic Lactobacillus reuteri	Other: Placebo; Solution without active Lactobacillus reuteri; Other Names: Inactive solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biomarkers of immune response	Between 18 and 32 weeks of age

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Andi L Shane, MD, MPH, MSc, Emory University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: probiotic; Lactobacillus reuteri DSM 17938; healthy infants
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: IRB00055040; ProBoost (Other Identifier: Other)