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Fermentation Rate of Infant Formula

This study is currently recruiting participants.
Verified July 2012 by Boys Town National Research Hospital
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
Boys Town National Research Hospital
ClinicalTrials.gov Identifier:
NCT01466400
First received: November 3, 2011
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boys Town National Research Hospital:

Primary Outcome Measures:
  • Hydrogen content of breath [ Time Frame: six hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: November 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
infants two to six months of age

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.

  Eligibility

Ages Eligible for Study:   2 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy infants.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466400

Contacts
Contact: Rose Pauley-Hunter, APRN (402) 778-6890 rosemary.pauley-hunter@boystown.org

Locations
United States, Nebraska
Boys Town National Research Hospital Recruiting
Omaha, Nebraska, United States, 68131
Contact: Rose Pauley-Hunter, APRN     402-778-6890     rosemary.pauley-hunter@boystown.org    
Principal Investigator: Laurel Prestridge, MD            
Sponsors and Collaborators
Boys Town National Research Hospital
Mead Johnson Nutrition
Investigators
Principal Investigator: Laurel Prestridge, MD Boys Town National Research Hospital
Principal Investigator: Sharad Kunnath, MD Boys Town National Research Hospital
  More Information

No publications provided

Responsible Party: Boys Town National Research Hospital
ClinicalTrials.gov Identifier: NCT01466400     History of Changes
Other Study ID Numbers: 11-18-F
Study First Received: November 3, 2011
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boys Town National Research Hospital:
health benefits of infant formula

ClinicalTrials.gov processed this record on June 18, 2013