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OpenTrials
Completed

NCT Number: NCT01466400

Fermentation Rate of Infant Formula

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

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Key information

Conditions

Healthy

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Boys Town National Research Hospital

Omaha, Nebraska, 68131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hydrogen content of breath

    Time frame: six hours

Sponsors and collaborators

Lead sponsor

Father Flanagan's Boys' Home

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 8, 2011
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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