Clinical trial NCT02746016: Effect of Formula on Infant Behavior
Official title: Effect of Formula Supplemented With Oligosaccharides on Infant Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 69
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: This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health as determined from subject's medical history by parent report
* Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
* Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* Subject is between 7 and 42 days of age
* Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
* Infant is exclusively formula-fed at time of study entry
* 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
* Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

Exclusion Criteria:

* An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
* Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (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 SD1) to within one day of initiation of study feeding (SD1)
Secondary outcomes:
measure: Fussiness
timeFrame: Baseline to SDAY 29
measure: Hours of daily crying
timeFrame: Baseline to SDAY 29
measure: Gastrointestinal Tolerance
timeFrame: Baseline to SDAY 29
measure: Stool Pattern
timeFrame: Baseline to SDAY 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Tucson
country: United States
facility: Watching Over Mothers and Babies
state: Arizona
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: Orlando
country: United States
facility: Florida Institute for Clinical Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Score Physician Alliance, LLC
state: Florida
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Cleveland
country: United States
facility: Institute of Clinical Research, LLC
state: Ohio
city: Grove City
country: United States
facility: Aventiv Research
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Southwest Children's Research Associates, P.A.
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD, RD
role: STUDY_CHAIR
References: