Effect of Probiotic Supplementation on Immune Function in Healthy Infants

Inflammation Clinical Trial

— ProBoost  

Official title:

Application of Therapeutic Microbiology to Improve Immunogenicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542320
• Other study ID #: IRB00055040
• Secondary ID: ProBoost
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: March 5, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 32 Weeks

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Inflammation

Intervention

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:
• Placebo
Solution without active Lactobacillus reuteri

Locations

Country	Name	City	State
United States	Emory Children's Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of immune response		Between 18 and 32 weeks of age	No