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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542320
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : March 6, 2015
The Gerber Foundation
Information provided by (Responsible Party):
Andi L. Shane, MD, Emory University

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

Condition or disease Intervention/treatment Phase
Inflammation Dietary Supplement: Lactobacillus reuteri DSM 17938 Other: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: BioGaia infant drops
Placebo Comparator: Placebo
Solution without the active probiotic Lactobacillus reuteri
Other: Placebo
Solution without active Lactobacillus reuteri
Other Name: Inactive solution

Primary Outcome Measures :
  1. Biomarkers of immune response [ Time Frame: Between 18 and 32 weeks of age ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01542320

United States, Georgia
Emory Children's Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
The Gerber Foundation
Principal Investigator: Andi L Shane, MD, MPH, MSc Emory University

Responsible Party: Andi L. Shane, MD, Assistant Professor of Pediatrics, Emory University Identifier: NCT01542320     History of Changes
Other Study ID Numbers: IRB00055040
ProBoost ( Other Identifier: Other )
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: November 2014

Keywords provided by Andi L. Shane, MD, Emory University:
Lactobacillus reuteri DSM 17938
healthy infants

Additional relevant MeSH terms:
Pathologic Processes