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Fermentation Rate of Infant Formula

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ClinicalTrials.gov Identifier: NCT01466400
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease
Healthy

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 Design

Study Type : Observational
Actual Enrollment : 13 participants
Time Perspective: Prospective
Study Start Date : November 2011
Primary Completion Date : November 2012
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
infants two to six months of age


Outcome Measures

Primary Outcome Measures :
  1. Hydrogen content of breath [ Time Frame: six hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy infants.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466400


Locations
United States, Nebraska
Boys Town National Research Hospital
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Boys Town National Research Hospital
Mead Johnson Nutrition
Investigators
Principal Investigator: Laurel Prestridge, MD Boys Town National Research Hospital
Principal Investigator: Sharad Kunnath, MD Boys Town National Research Hospital
More Information

Responsible Party: Boys Town National Research Hospital
ClinicalTrials.gov Identifier: NCT01466400     History of Changes
Other Study ID Numbers: 11-18-F
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Boys Town National Research Hospital:
health benefits of infant formula