Clinical trial NCT03967132: Growth and Tolerance of Infants Fed Milk-Based Infant Formula
Official title: Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 189
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.


Eligibility criteria: Inclusion Criteria:

* Good health as determined from participant's medical history
* Singleton from a full-term birth with a gestational age of 37-42 weeks
* Birth weight was \> 2490 g (\~5 lbs. 8 oz.)
* If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
* If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
* Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
* Participant participates in another study that has not been approved as a concomitant study by AN.

Primary outcomes:
measure: Weight
timeFrame: Day of life 14 - 119
Secondary outcomes:
measure: Stool Characteristics
timeFrame: Study Day 1 to Day of life 119
measure: Formula Tolerance
timeFrame: Study Day 1 to Day of life 119
measure: Length
timeFrame: Study Day 1 to Day of life 119
measure: Head Circumference (HC)
timeFrame: Study Day 1 to Day of life 119
measure: Illness Incidence
timeFrame: Study Day 1 to Day of life 119
Other outcomes:
measure: Stool Sample
timeFrame: Study Day 1 to Day of life 119
Locations:
city: Tucson
country: United States
facility: Watching Over Mothers & Babies
state: Arizona
city: Sacramento
country: United States
facility: Pediatric Medical Associates
state: California
city: Norwich
country: United States
facility: Norwich Pediatric Group, P.C.
state: Connecticut
city: Miami
country: United States
facility: Phoenix Medical Research LLC
state: Florida
city: Orlando
country: United States
facility: University Clinical Research-Deland, LLC a/b/a Accel Clinical Research
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Nicholasville
country: United States
facility: Michael W. Simon, M.D., PSC
state: Kentucky
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Mentor
country: United States
facility: Institute of Clinical Research, LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Midsouth Center for Clinical Research
state: Tennessee
city: Austin
country: United States
facility: ARC Clinical Research at Wilson Parke
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group, LLC 3078
state: Texas
city: Pearland
country: United States
facility: Kagan Pediatrics - HD Research Corporation
state: Texas
city: Plano
country: United States
facility: Plano Pediatrics - ACRC Trials
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Timberly Williams, PhD
role: STUDY_CHAIR
References: