Fermentation Rate of Infant Formula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01466400
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : July 23, 2015
Mead Johnson Nutrition
Information provided by (Responsible Party):
Father Flanagan’s Boys’ Home

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

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 Type : Observational
Actual Enrollment : 13 participants
Time Perspective: Prospective
Study Start Date : November 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

infants two to six months of age

Primary Outcome Measures :
  1. Hydrogen content of breath [ Time Frame: six hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01466400

United States, Nebraska
Boys Town National Research Hospital
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Father Flanagan’s Boys’ Home
Mead Johnson Nutrition
Principal Investigator: Laurel Prestridge, MD Father Flanagan’s Boys’ Home
Principal Investigator: Sharad Kunnath, MD Father Flanagan’s Boys’ Home

Responsible Party: Father Flanagan’s Boys’ Home Identifier: NCT01466400     History of Changes
Other Study ID Numbers: 11-18-F
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Father Flanagan’s Boys’ Home:
health benefits of infant formula