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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TERMINATED
NA
168 participants
INTERVENTIONAL
2020-08-10
2021-04-12
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
QUADRUPLE
Study Groups
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Control Feeding Group
Ready to feed milk-based product
Control Infant Formula
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Control Toddler Drink
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Experimental Feeding Group
Ready to feed milk-based product with oligosaccharides
Experimental Infant Formula
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Experimental Toddler Drink
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Human Milk (HM) Reference Group
HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product
Supplemental Formula for HM Group
Ad libitum formula given up to 12 months of age if HM is supplemented
Toddler Drink for HM group
16 fl oz per day if weaned from HM feedings
Interventions
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Control Infant Formula
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Control Toddler Drink
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Experimental Infant Formula
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Experimental Toddler Drink
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Supplemental Formula for HM Group
Ad libitum formula given up to 12 months of age if HM is supplemented
Toddler Drink for HM group
16 fl oz per day if weaned from HM feedings
Eligibility Criteria
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Inclusion Criteria
* Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks
* Participant's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
* If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
* If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
* If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
* Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
* 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
* Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
* Participant is in another study that has not been approved as a concomitant study
* Participant has been treated with antibiotics 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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Bridget Barrett Reis, PhD, RD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Southeastern Pediatric Associates
Dothan, Alabama, United States
Eclipse Clinical Research
Tucson, Arizona, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Boeson Research 3266
Grand Junction, Colorado, United States
TOPAZ Clinical Research, Inc.
Apopka, Florida, United States
ASCLEPES Research Centers
Spring Hill, Florida, United States
Meridian Clinical Research 3259
Macon, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Leavitt Clinical Research
Idaho Falls, Idaho, United States
Qualmedica Research 3272
Evansville, Indiana, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Qualmedica Research, LLC 3270
Owensboro, Kentucky, United States
Meridian Clinical Research 3080
Baton Rouge, Louisiana, United States
Boeson Research 3265
Kalispell, Montana, United States
Boeson Research 3267
Missoula, Montana, United States
Meridian Clinical Research 3264
Grand Island, Nebraska, United States
Meridian Clinical Research 3263
Hastings, Nebraska, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Holston Medical Group
Kingsport, Tennessee, United States
MultiCare Institute for Research & Innovation
Dickinson, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
PAS Research 3273
McAllen, Texas, United States
Multicare Rockwood Pediatrics
Spokane, Washington, United States
Mercury Clinical Research 3261
Tacoma, Washington, United States
Countries
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Other Identifiers
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AL38
Identifier Type: -
Identifier Source: org_study_id
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