NCT01542320

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

February 21, 2012

Last Update Submit

March 5, 2015

Conditions

Inflammation

Keywords

probioticLactobacillus reuteri DSM 17938healthy infants

Outcome Measures

Primary Outcomes (1)

  • Biomarkers of immune response

    Between 18 and 32 weeks of age

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus reuteri DSM 17938

Dietary Supplement: Lactobacillus reuteri DSM 17938

Placebo

PLACEBO COMPARATOR

Solution without the active probiotic Lactobacillus reuteri

Other: Placebo

Interventions

Lactobacillus reuteri DSM 17938DIETARY_SUPPLEMENT

1 x 10e8 colony forming units in 5 drops (0.17ml)daily from study enrollment to study conclusion. Duration based on rotavirus vaccine administration.

Also known as: BioGaia infant drops
Probiotic
PlaceboOTHER

Solution without active Lactobacillus reuteri

Also known as: Inactive solution
Placebo

Eligibility Criteria

Age6 Weeks - 32 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andi L Shane, MD, MPH, MSc

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 2, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 6, 2015

Record last verified: 2014-11

Locations

US(1)