BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)

NACompletedINTERVENTIONAL
Enrollment

607

Participants

Timeline

Start Date

July 21, 2021

Primary Completion Date

May 12, 2025

Study Completion Date

May 12, 2025

Conditions
Growth
Interventions
OTHER

Control Infant Formula

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

OTHER

Control Toddler Drink

\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

OTHER

Experimental Infant Formula

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

OTHER

Experimental Toddler Drink

\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

OTHER

Human Milk

Ad libitum or as instructed by HCP

OTHER

Human Milk Supplemental Formula

Ad libitum if consuming supplemented formula; feeding period up to 12 months of age

OTHER

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

Trial Locations (42)

10468

Advantage Clinical Trials, The Bronx

23294

National Clinical Research, Inc, Richmond

29301

Tribe Clinical Research LLC 3382, Spartanburg

29486

Coastal Pediatric Research, Summerville

29607

Tribe Clinical Research LLC 3313, Greenville

31210

Meridian Clinical Research 3259, Macon

32405

Emerald Coast OBGYN Clinical Research, Panama City

32703

TOPAZ Clinical Research, Inc., Apopka

33125

Columbus Clinical Services, LLC., Miami

33617

Jedidiah Clinical Research, Tampa

34609

ASCLEPES Research Centers, Spring Hill

37620

Holston Medical Group 3301, Bristol

37660

Holston Medical Group 3046, Kingsport

38115

AVIATI Healthcare & Clinical Research, Memphis

42301

Qualmedica Research, LLC, Owensboro

45414

Ohio Pediatric Research Association, Dayton

47715

Qualmedica Research, Evansville

47725

Deaconess Clinic, Inc., Evansville

59405

Boeson Research 3367, Great Falls

59804

Boeson Research 3267, Missoula

59901

Boeson Research 3265, Kalispell

68117

University of Nebraska Medical Center 3315, Omaha

68131

University of Nebraska Medical Center 3314, Omaha

68510

Meridian Clinical Research 3304, Lincoln

68526

Alivation Research, Lincoln

68803

Meridian Clinical Research 3264, Grand Island

68901

Meridian Clinical Research 3263, Hastings

70433

MedPharmics, LLC 3343, Covington

70458

MedPharmics Research 3369, Slidell

70808

Pennington Biomedical Research Center, Baton Rouge

71913

HealthStar Research, LLC, Hot Springs

71943

HealthStar Research, Glenwood

72019

Applied Research Center of Arkansas, Little Rock

72401

The Children's Clinic of Jonesboro, P.A., Jonesboro

75230

Javara Inc. 3377, Dallas

77573

Maximos Ob/Gyn, League City

80922

Optumcare Colorado Springs, LLC, Colorado Springs

81505

Boeson Research 3266, Grand Junction

83404

Clinical Research Prime, Idaho Falls

Leavitt Clinical Research, Idaho Falls

85015

MedPharmics, LLC 3192, Phoenix

99202

Multicare Health System - Rockwood Pediatrics, Spokane

All Listed Sponsors
lead

Abbott Nutrition

INDUSTRY

NCT04957992 - BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs) | Biotech Hunter | Biotech Hunter