Tolerance
Conditions
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.
Interventions
Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide
Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean rank stool consistency (MRSC) | Study Day 1 to 28 Days of Age | Parent Completed Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length | 14 to 119 Days of Age | Interval length gain per day |
| Head Circumference | 14 to 119 Days of Age | Interval head circumference gain per day |
| Weight | 14 to 119 Days of Age | Interval weight gain per day |
| Gastrointestinal tolerance | 14 to 119 Days of Age | Parent Completed Diary |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant Feeding and Stool Patterns Questionnaire | Exit or 119 Days of Age | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction |
| Infant Behavior Questionnaire | Exit or 119 Days of Age | Parent completed questionnaire; 22 questions with 5-point Likert scale questions; scaled in the negative direction |
| Formula Satisfaction Questionnaire | Exit or 119 Days of Age | Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction |
| Adverse Events | Study Day 1 to 119 Days of Age | Standard adverse event reporting |
| Infant Stool Characteristics | Study Day 1 to 119 Days of Age | Parent Completed Diary |
| Study Product Intake | Study Day 1 to 119 Days of Age | Parent Completed Diary |
| Infant and Household Characteristics | Study Day 1 to 119 Days of Age | Parent reported lifestyle and illness questions |
| Health Resource Utilization | Study Day 1 to 119 Days of Age | Number of Visits |
Countries
United States
Outcome results
None listed