Clinical trial NCT04529759: Healthy Term Infants Fed Milk-Based Infant Formula
Official title: Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 108
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.


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.)
* 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, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (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 gastrointestinal (GI) tolerance
* Participant is enrolled in another study that has not been approved as a concomitant study

Primary outcomes:
measure: Mean rank stool consistency (MRSC)
timeFrame: Study Day 1 to 28 Days of Age
Secondary outcomes:
measure: Weight
timeFrame: 14 to 119 Days of Age
measure: Gastrointestinal tolerance
timeFrame: 14 to 119 Days of Age
measure: Length
timeFrame: 14 to 119 Days of Age
measure: Head Circumference
timeFrame: 14 to 119 Days of Age
Other outcomes:
measure: Infant Stool Characteristics
timeFrame: Study Day 1 to 119 Days of Age
measure: Study Product Intake
timeFrame: Study Day 1 to 119 Days of Age
measure: Infant and Household Characteristics
timeFrame: Study Day 1 to 119 Days of Age
measure: Health Resource Utilization
timeFrame: Study Day 1 to 119 Days of Age
measure: Infant Feeding and Stool Patterns Questionnaire
timeFrame: Exit or 119 Days of Age
measure: Infant Behavior Questionnaire
timeFrame: Exit or 119 Days of Age
measure: Formula Satisfaction Questionnaire
timeFrame: Exit or 119 Days of Age
measure: Adverse Events
timeFrame: Study Day 1 to 119 Days of Age
Locations:
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Tampa
country: United States
facility: PAS Research, LLC
state: Florida
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Mentor
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Westlake
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Memphis
country: United States
facility: Midsouth Center for Clinical Research
state: Tennessee
Study officials:
affiliation: Abbott Nutrition
name: John Lasekan, PhD
role: STUDY_CHAIR
References: