Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2018-08-28
2018-11-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Hydrolysate Infant Formula 1
Ready to feed infant formula in can
Hydrolysate Infant Formula 1
Feed ad lib
Hydrolysate Infant Formula 2
Ready to feed infant formula in bottle
Hydrolysate Infant Formula 2
Feed ad lib
Interventions
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Hydrolysate Infant Formula 1
Feed ad lib
Hydrolysate Infant Formula 2
Feed ad lib
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Courtney Allgeier, MS, RD, LD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Watching Over Mothers and Babies
Tucson, Arizona, United States
Springs Medical Research
Owensboro, Kentucky, United States
The Cleveland Pediatric Research Center, LLC
Cleveland, Ohio, United States
Institute of Clinical Research, LLC
Mentor, Ohio, United States
Midsouth Center for Clinical Research
Memphis, Tennessee, United States
Countries
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Other Identifiers
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AL30
Identifier Type: -
Identifier Source: org_study_id