NCT01466400

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

November 3, 2011

Last Update Submit

July 21, 2015

Conditions

Healthy

Keywords

health benefits of infant formula

Outcome Measures

Primary Outcomes (1)

  • Hydrogen content of breath

    six hours

Study Arms (1)

infants two to six months of age

Eligibility Criteria

Age2 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy infants.

You may qualify if:

  • months of age,
  • healthy,receiving standard cow-milk based infant formula weight,
  • greater than 5th percentile

You may not qualify if:

  • on no antibiotics,
  • breastfed,
  • on solid foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boys Town National Research Hospital

Omaha, Nebraska, 68131, United States

Location

Study Officials

  • Laurel Prestridge, MD

    Father Flanagan's Boys' Home

    PRINCIPAL INVESTIGATOR

  • Sharad Kunnath, MD

    Father Flanagan's Boys' Home

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

August 1, 2013

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

US(1)