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

This study is currently recruiting participants.

Verified November 2012 by Emory University

Sponsor:

Collaborator:

The Gerber Foundation

Information provided by (Responsible Party):

Andi L. Shane, MD, Emory University

ClinicalTrials.gov Identifier:

NCT01542320

First received: February 21, 2012

Last updated: November 6, 2012

Last verified: November 2012

History of Changes

Purpose

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

Condition	Intervention
Inflammation	Dietary Supplement: Lactobacillus reuteri DSM 17938 Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	Application of Therapeutic Microbiology to Improve Immunogenicity

Resource links provided by NLM:

Drug Information available for: Lactobacillus

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Biomarkers of immune response [ Time Frame: Between 18 and 32 weeks of age ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	6 Weeks to 32 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542320

Locations

United States, Georgia
Emory Children's Center	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Andi L Shane, MD, MPH, MSc 404-727-5642 ashane@emory.edu
Contact: Leslie Smitley, RN 404.727.5642 lsmitle@emory.edu
Principal Investigator: Andi L Shane, MD, MPH, MSc

Sponsors and Collaborators

Emory University

The Gerber Foundation

Investigators

Principal Investigator:

Andi L Shane, MD, MPH, MSc

Emory University

More Information

No publications provided

Responsible Party:	Andi L. Shane, MD, Assistant Professor of Pediatrics, Emory University
ClinicalTrials.gov Identifier:	NCT01542320 History of Changes
Other Study ID Numbers:	ProBoost
Study First Received:	February 21, 2012
Last Updated:	November 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

probiotic
Lactobacillus reuteri DSM 17938
healthy infants

Additional relevant MeSH terms:

Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013

To Top