Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics

Status: Completed
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 1 month
Healthy Volunteers: t
View:

• Subject is judged to be in good health.

• Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.

• Subject's birth weight was ≥ 2490 g (\

⁃ 5 lbs. 8 oz.).

• Infant was identified by parents as very fussy or extremely fussy.

• Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.

• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Locations
United States
Alabama
Southeastern Pediatric Associates
Dothan
Florida
Pensacola Research Consultants, Inc
Pensacola
Score Physician Alliance, LLC
Saint Petersburg
Indiana
Deaconess Clinic, Inc.
Evansville
Kentucky
Kentucky Pediatric/Adult Research
Bardstown
Nebraska
Women's Clinic of Lincoln, PC
Lincoln
Ohio
Aventiv Research
Grove City
South Carolina
Coastal Pediatric Research
Charleston
Tennessee
Holston Medical Group
Bristol
Holston Medical Group
Kingsport
Texas
Southwest Children's Research Associates, P.A.
San Antonio
Time Frame
Start Date: 2016-05
Completion Date: 2017-05-02
Participants
Target number of participants: 59
Treatments
Experimental: Infant formula supplemented with prebiotics
infant formula powder, feed ad libitum
Sponsors
Leads: Abbott Nutrition

This content was sourced from clinicaltrials.gov