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ProBoost: Effect of Probiotic Supplementation on Immune Function in Healthy Infants

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT01542320
Collaborator
The Gerber Foundation (Other)
15
Enrollment
1
Location
2
Arms
33
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Lactobacillus reuteri DSM 17938
  • Other: Placebo
 N/A

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 Design

Study Type:
Interventional
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 :
Mar 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Biomarkers of immune response [Between 18 and 32 weeks of age]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Weeks to 32 Weeks
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory Children's Center Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University
    • The Gerber Foundation

    Investigators

    • Principal Investigator: Andi L Shane, MD, MPH, MSc, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andi L. Shane, MD, Assistant Professor of Pediatrics, Emory University
    ClinicalTrials.gov Identifier:
    NCT01542320
    Other Study ID Numbers:
    • IRB00055040
    • ProBoost
    First Posted:
    Mar 2, 2012
    Last Update Posted:
    Mar 6, 2015
    Last Verified:
    Nov 1, 2014
    Keywords provided by Andi L. Shane, MD, Assistant Professor of Pediatrics, Emory University
    probiotic
    Lactobacillus reuteri DSM 17938
    healthy infants
    Additional relevant MeSH terms:
    Inflammation

    Study Results

    No Results Posted as of Mar 6, 2015