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.|
|ClinicalTrials.gov Identifier: NCT01466400|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : July 23, 2015
|Condition or disease|
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|
|Study Start Date :||November 2011|
|Primary Completion Date :||November 2012|
|Study Completion Date :||August 2013|
|infants two to six months of age|
- Hydrogen content of breath [ Time Frame: six hours ]
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 ClinicalTrials.gov identifier (NCT number): NCT01466400
|United States, Nebraska|
|Boys Town National Research Hospital|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Laurel Prestridge, MD||Father Flanagan’s Boys’ Home|
|Principal Investigator:||Sharad Kunnath, MD||Father Flanagan’s Boys’ Home|