Clinical trial NCT02322138: Gastrointestinal Tolerance of Infant Formula
Official title: Gastrointestinal Tolerance of Formula Supplemented With Prebiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 131
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.


Eligibility criteria: Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.).
* Infant is between 0 and 8 days of age at enrollment.
* Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) 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:

* Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
* Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
* Mother intends to use a combination of breast and formula feeding.
* Participation in another study that has not been approved as a concomitant study by AN.

Primary outcomes:
measure: Stool Consistency Questionnaire
timeFrame: Baseline to 35 Days of Age
Secondary outcomes:
measure: Stools per Day Questionnaire
timeFrame: Baseline to 35 Days of Age
measure: Feeding Spit Up Questionnaire
timeFrame: Baseline to 35 Days of Age
measure: Weight
timeFrame: Baseline to 35 Days of Age
measure: Length
timeFrame: Baseline to 35 Days of Age
measure: Head Circumference
timeFrame: Baseline to 35 Days of Age
Other outcomes:
Locations:
city: Tucson
country: United States
facility: W.O.M.B Watching Over Mothers and Babies
state: Arizona
city: Colorado Springs
country: United States
facility: Clinical Research Advantage/Colorado Springs Health Partners
state: Colorado
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance, LLC
state: Florida
city: Nicholasville
country: United States
facility: Michael W. Simon, M.D., PSC
state: Kentucky
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC.
state: Nebraska
city: Asheboro
country: United States
facility: White Oak Family Physicians DBA Asheboro Research Associates
state: North Carolina
city: Mayfield Heights,
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Middleburg Heights
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Layton
country: United States
facility: Tanner Memorial Clinic
state: Utah
Study officials:
affiliation: Abbott Nutrition
name: Janice Kajzer, MS, RD, LD
role: STUDY_CHAIR
References: