Fermentation Rate of Infant Formula

Completed

• Conditions: Healthy

• Registration Number: NCT01466400
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-08
• Primary Completion: 2012-11
• Study Completion: 2013-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hydrogen content of breath	six hours

Trial Locations

Locations (1)

Boys Town National Research Hospital; 🇺🇸 Omaha, Nebraska, United States