Trials / Completed
CompletedNCT01466400
Fermentation Rate of Infant Formula
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 13 (actual)
- Sponsor
- Father Flanagan's Boys' Home · Academic / Other
- Sex
- All
- Age
- 2 Months – 6 Months
- Healthy volunteers
- Accepted
Summary
It is hypothesized that there will be no difference in the breath hydrogen excretion between the 2 different prebiotic formulas.
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.
Conditions
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-11-01
- Completion
- 2013-08-01
- First posted
- 2011-11-08
- Last updated
- 2015-07-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01466400. Inclusion in this directory is not an endorsement.