Fermentation Rate of Infant Formula
Recruitment status was Recruiting
It is hypothesized that there will be no difference in the breath hydrogen excretion between the 2 different prebiotic formulas.
|Study Design:||Time Perspective: Prospective|
- Hydrogen content of breath [ Time Frame: six hours ] [ Designated as safety issue: No ]
|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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466400
|Contact: Rose Pauley-Hunter, APRN||(402) firstname.lastname@example.org|
|United States, Nebraska|
|Boys Town National Research Hospital||Recruiting|
|Omaha, Nebraska, United States, 68131|
|Contact: Rose Pauley-Hunter, APRN 402-778-6890 email@example.com|
|Principal Investigator: Laurel Prestridge, MD|
|Principal Investigator:||Laurel Prestridge, MD||Boys Town National Research Hospital|
|Principal Investigator:||Sharad Kunnath, MD||Boys Town National Research Hospital|