Fermentation Rate of Infant Formula

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01466400

Enrollment

Registered

2011-11-08

Start date

2011-11-30

Completion date

2013-08-31

Last updated

2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

health benefits of infant formula

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 6 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Hydrogen content of breath	six hours

Countries

United States

Outcome results