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Fermentation Rate of Infant Formula

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Boys Town National Research Hospital.
Recruitment status was  Recruiting
Mead Johnson Nutrition
Information provided by (Responsible Party):
Boys Town National Research Hospital Identifier:
First received: November 3, 2011
Last updated: July 24, 2012
Last verified: July 2012

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


Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

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)
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.


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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01466400

Contact: Rose Pauley-Hunter, APRN (402) 778-6890

United States, Nebraska
Boys Town National Research Hospital Recruiting
Omaha, Nebraska, United States, 68131
Contact: Rose Pauley-Hunter, APRN    402-778-6890   
Principal Investigator: Laurel Prestridge, MD         
Sponsors and Collaborators
Boys Town National Research Hospital
Mead Johnson Nutrition
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 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 processed this record on March 03, 2015