Fermentation Rate of Infant Formula

This study has been completed.
Mead Johnson Nutrition
Information provided by (Responsible Party):
Boys Town National Research Hospital
ClinicalTrials.gov Identifier:
First received: November 3, 2011
Last updated: July 21, 2015
Last verified: July 2015
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 ]

Enrollment: 13
Study Start Date: November 2011
Study Completion Date: August 2013
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01466400

United States, Nebraska
Boys Town National Research Hospital
Omaha, Nebraska, United States, 68131
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
ClinicalTrials.gov Identifier: NCT01466400     History of Changes
Other Study ID Numbers: 11-18-F
Study First Received: November 3, 2011
Last Updated: July 21, 2015
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 November 27, 2015