Fermentation Rate of Infant Formula

Father Flanagan's Boys' Home

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01466400

11-18-F

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

13 participants in 1 patient group

infants two to six months of age