NCT03628183CompletedNot Applicable
Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 51
- Locations
- 5
- Primary Endpoint
- Stool Characteristics
Study Overview
Brief Summary
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- — to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is judged to be in good health
- •Singleton from a full-term birth
- •Birth weight was > or = to 2490 g
- •Between 0 and 14 days of age at enrollment
- •Parent(s) confirm their intention to feed their infant the assigned 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, 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)
Exclusion Criteria
- •An adverse maternal, fetal or subject medical history that is thought by the investigator to have 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 an allergy or intolerance to any ingredient in the study product
- •Subject has been treated with antibiotics within 2 weeks prior to enrollment
Arms & Interventions
Hydrolysate Infant Formula 1
Active Comparator
Ready to feed infant formula in can
Intervention: Hydrolysate Infant Formula 1 (Other)
Hydrolysate Infant Formula 2
Experimental
Ready to feed infant formula in bottle
Intervention: Hydrolysate Infant Formula 2 (Other)
Outcomes
Primary Outcomes
Stool Characteristics
Time Frame: Study Day 1 - Study Day 21
Parent completed diary
Secondary Outcomes
- Length(Study Day 1 - Study Day 21)
- Formula Intake(Study Day 1 - Study Day 21)
- Weight(Study Day 1 - Study Day 21)
Investigators
Study Sites (5)
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