BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)
Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
1 other identifier
interventional
607
1 country
42
Brief Summary
The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2021
CompletedFirst Posted
Study publicly available on registry
July 12, 2021
CompletedStudy Start
First participant enrolled
July 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2025
CompletedJune 27, 2025
June 1, 2025
3.8 years
July 1, 2021
June 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Growth
weight for age z-score
Study Day 1 to 6 Months of Age
Secondary Outcomes (8)
Incidence of respiratory infection between study groups
Study Day 1 to 24 Months of Age
Number of respiratory infection episodes between study groups
Study Day 1 to 24 Months of Age
Incidence of infection morbidity between study groups
Study Day 1 to 24 Months of Age
Number of episodes of infection morbidity between study groups
Study Day 1 to 24 Months of Age
Weight
Study Day 1 to 24 Months of Age
- +3 more secondary outcomes
Other Outcomes (15)
Formula Satisfaction Questionnaire
28 Days of Age to 6 Months of Age
Toddler Drink Satisfaction Questionnaire
18 Months of Age to 24 Months of Age
Infant Feeding and Stool Patterns Questionnaire
28 Days of Age to 119 Days of Age]
- +12 more other outcomes
Study Arms (3)
Control Feeding Group
ACTIVE COMPARATORMilk based product
Experimental Feeding Group
EXPERIMENTALMilk based product with oligosaccharides
Human Milk Reference Group
OTHERHuman Milk
Interventions
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Ad libitum if consuming supplemented formula; feeding period up to 12 months of age
\~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age
Eligibility Criteria
You may qualify if:
- Participant is judged to be in good health as determined from participant's medical history
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (42)
MedPharmics, LLC 3192
Phoenix, Arizona, 85015, United States
HealthStar Research
Glenwood, Arkansas, 71943, United States
HealthStar Research, LLC
Hot Springs, Arkansas, 71913, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72019, United States
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, 80922, United States
Boeson Research 3266
Grand Junction, Colorado, 81505, United States
TOPAZ Clinical Research, Inc.
Apopka, Florida, 32703, United States
Columbus Clinical Services, LLC.
Miami, Florida, 33125, United States
Emerald Coast OBGYN Clinical Research
Panama City, Florida, 32405, United States
ASCLEPES Research Centers
Spring Hill, Florida, 34609, United States
Jedidiah Clinical Research
Tampa, Florida, 33617, United States
Meridian Clinical Research 3259
Macon, Georgia, 31210, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Leavitt Clinical Research
Idaho Falls, Idaho, 83404, United States
Qualmedica Research
Evansville, Indiana, 47715, United States
Deaconess Clinic, Inc.
Evansville, Indiana, 47725, United States
Qualmedica Research, LLC
Owensboro, Kentucky, 42301, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MedPharmics, LLC 3343
Covington, Louisiana, 70433, United States
MedPharmics Research 3369
Slidell, Louisiana, 70458, United States
Boeson Research 3367
Great Falls, Montana, 59405, United States
Boeson Research 3265
Kalispell, Montana, 59901, United States
Boeson Research 3267
Missoula, Montana, 59804, United States
Meridian Clinical Research 3264
Grand Island, Nebraska, 68803, United States
Meridian Clinical Research 3263
Hastings, Nebraska, 68901, United States
Meridian Clinical Research 3304
Lincoln, Nebraska, 68510, United States
Alivation Research
Lincoln, Nebraska, 68526, United States
University of Nebraska Medical Center 3315
Omaha, Nebraska, 68117, United States
University of Nebraska Medical Center 3314
Omaha, Nebraska, 68131, United States
Advantage Clinical Trials
The Bronx, New York, 10468, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Tribe Clinical Research LLC 3313
Greenville, South Carolina, 29607, United States
Tribe Clinical Research LLC 3382
Spartanburg, South Carolina, 29301, United States
Coastal Pediatric Research
Summerville, South Carolina, 29486, United States
Holston Medical Group 3301
Bristol, Tennessee, 37620, United States
Holston Medical Group 3046
Kingsport, Tennessee, 37660, United States
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, 38115, United States
Javara Inc. 3377
Dallas, Texas, 75230, United States
Maximos Ob/Gyn
League City, Texas, 77573, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
Multicare Health System - Rockwood Pediatrics
Spokane, Washington, 99202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elizabeth Reverri, PhD, MS, RD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2021
First Posted
July 12, 2021
Study Start
July 21, 2021
Primary Completion
May 12, 2025
Study Completion
May 12, 2025
Last Updated
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share