Clinical trial NCT02757924: Behavior of Infants Fed Formula Supplemented With Prebiotics
Official title: Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 59
Sex: ALL
Minimum age (years): 7
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
* Subject participates in another study that has not been approved as a concomitant study.
* Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment.
* Subject has been treated with oral antibiotics within 7 days prior to study enrollment.
* Mother intends to use a combination of breast and formula feeding.

Primary outcomes:
measure: Fussiness
timeFrame: Change from baseline (3 days prior to study day 1) to within 1 day of initiation of study feeding
Secondary outcomes:
measure: Fussiness
timeFrame: Baseline to Day 29
measure: Hours of Daily Crying
timeFrame: Baseline to Day 29
measure: Gastrointestinal Tolerance
timeFrame: Baseline to Day 29
measure: Stool Pattern
timeFrame: Baseline to Day 29
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Pensacola
country: United States
facility: Pensacola Research Consultants, Inc
state: Florida
city: Saint Petersburg
country: United States
facility: Score Physician Alliance, LLC
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Grove City
country: United States
facility: Aventiv Research
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: San Antonio
country: United States
facility: Southwest Children's Research Associates, P.A.
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD, RD, LD
role: STUDY_CHAIR
References: