Fermentation Rate of Infant Formula

Father Flanagan's Boys' Home13 enrolled

Overview

It is hypothesized that there will be no difference in the breath hydrogen excretion between the 2 different prebiotic formulas.

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

Enrollment

Conditions

Healthy

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Boys Town National Research Hospital

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Hydrogen content of breath

Time frame: six hours

Data from ClinicalTrials.gov

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