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Fermentation Rate of Infant Formula

Sponsor
Father Flanagan's Boys' Home (Other)
Overall Status
Completed
CT.gov ID
NCT01466400
Collaborator
Mead Johnson Nutrition (Industry)
13
Enrollment
1
Location
21
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is hypothesized that there will be no difference in the breath hydrogen excretion between the 2 different prebiotic formulas.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This pilot study is looking at how a formula with one of two different prebiotic blends may alter the hydrogen level in an infant's exhalations in the hours after feeding. Higher levels for a longer period may signal higher levels of short chain fatty acids and bifidobacteria, both beneficial for gastrointestinal health. The higher levels may be the result of the formula undergoing a slower digestion, producing more fermentation.

    The study will compare a formula, similar to one currently on the market, with added prebiotics using a special breathing mask designed to be held to the infant's mouth and nose long enough to capture the infant's exhaled breath which will then be tested for Hydrogen content.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    13 participants
    Time Perspective:
    Prospective
    Study Start Date :
    Nov 1, 2011
    Actual Primary Completion Date :
    Nov 1, 2012
    Actual Study Completion Date :
    Aug 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    infants two to six months of age

    Outcome Measures

    Primary Outcome Measures

    1. Hydrogen content of breath [six hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months to 6 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 2-6 months of age,

    • healthy,receiving standard cow-milk based infant formula weight,

    • greater than 5th percentile

    Exclusion Criteria:

    • on no antibiotics,

    • breastfed,

    • on solid foods

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boys Town National Research Hospital Omaha Nebraska United States 68131

    Sponsors and Collaborators

    • Father Flanagan's Boys' Home
    • Mead Johnson Nutrition

    Investigators

    • Principal Investigator: Laurel Prestridge, MD, Father Flanagan's Boys' Home
    • Principal Investigator: Sharad Kunnath, MD, Father Flanagan's Boys' Home

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Father Flanagan's Boys' Home
    ClinicalTrials.gov Identifier:
    NCT01466400
    Other Study ID Numbers:
    • 11-18-F
    First Posted:
    Nov 8, 2011
    Last Update Posted:
    Jul 23, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by Father Flanagan's Boys' Home
    health benefits of infant formula

    Study Results

    No Results Posted as of Jul 23, 2015