BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)
NCT ID: NCT04957992
Last Updated: 2025-06-27
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
607 participants
INTERVENTIONAL
2021-07-21
2025-05-12
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
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
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 Reference Group
Human Milk
Human Milk
Ad libitum or as instructed by HCP
Human Milk Supplemental Formula
Ad libitum if consuming supplemented formula; feeding period up to 12 months of age
Human Milk Toddler Drink
\~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age
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
Human Milk
Ad libitum or as instructed by HCP
Human Milk Supplemental Formula
Ad libitum if consuming supplemented formula; feeding period up to 12 months of age
Human Milk Toddler Drink
\~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age
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 by parent report
* Participant's 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 feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life
* Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
* Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP
* 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
* If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age.
* If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.
Exclusion Criteria
* Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant
* Suspected maternal substance abuse including alcohol
* Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), 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 by AN
* Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment
* Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment
0 Days
14 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Reverri, PhD, MS, RD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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MedPharmics, LLC 3192
Phoenix, Arizona, United States
HealthStar Research
Glenwood, Arkansas, United States
HealthStar Research, LLC
Hot Springs, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, United States
Boeson Research 3266
Grand Junction, Colorado, United States
TOPAZ Clinical Research, Inc.
Apopka, Florida, United States
Columbus Clinical Services, LLC.
Miami, Florida, United States
Emerald Coast OBGYN Clinical Research
Panama City, Florida, United States
ASCLEPES Research Centers
Spring Hill, Florida, United States
Jedidiah Clinical Research
Tampa, 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
Evansville, Indiana, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Qualmedica Research, LLC
Owensboro, Kentucky, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
MedPharmics, LLC 3343
Covington, Louisiana, United States
MedPharmics Research 3369
Slidell, Louisiana, United States
Boeson Research 3367
Great Falls, Montana, 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
Meridian Clinical Research 3304
Lincoln, Nebraska, United States
Alivation Research
Lincoln, Nebraska, United States
University of Nebraska Medical Center 3315
Omaha, Nebraska, United States
University of Nebraska Medical Center 3314
Omaha, Nebraska, United States
Advantage Clinical Trials
The Bronx, New York, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Tribe Clinical Research LLC 3313
Greenville, South Carolina, United States
Tribe Clinical Research LLC 3382
Spartanburg, South Carolina, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
Holston Medical Group 3301
Bristol, Tennessee, United States
Holston Medical Group 3046
Kingsport, Tennessee, United States
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, United States
Javara Inc. 3377
Dallas, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
National Clinical Research, Inc
Richmond, Virginia, United States
Multicare Health System - Rockwood Pediatrics
Spokane, Washington, United States
Countries
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Other Identifiers
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AL51
Identifier Type: -
Identifier Source: org_study_id
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