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

June 24, 2025 updated by: Abbott Nutrition

Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
607

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • MedPharmics, LLC 3192
    • Arkansas
      • Glenwood, Arkansas, United States, 71943
        • Healthstar Research
      • Hot Springs, Arkansas, United States, 71913
        • HealthStar Research, LLC
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro, P.A.
      • Little Rock, Arkansas, United States, 72019
        • Applied Research Center of Arkansas
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
        • Optumcare Colorado Springs, LLC
      • Grand Junction, Colorado, United States, 81505
        • Boeson Research 3266
    • Florida
      • Apopka, Florida, United States, 32703
        • Topaz Clinical Research, Inc.
      • Miami, Florida, United States, 33125
        • Columbus Clinical Services, LLC.
      • Panama City, Florida, United States, 32405
        • Emerald Coast OBGYN Clinical Research
      • Spring Hill, Florida, United States, 34609
        • Asclepes Research Centers
      • Tampa, Florida, United States, 33617
        • Jedidiah Clinical Research
    • Georgia
      • Macon, Georgia, United States, 31210
        • Meridian Clinical Research 3259
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Clinical Research
    • Indiana
      • Evansville, Indiana, United States, 47725
        • Deaconess Clinic, Inc.
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Qualmedica Research, LLC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
      • Covington, Louisiana, United States, 70433
        • MedPharmics, LLC 3343
      • Slidell, Louisiana, United States, 70458
        • MedPharmics Research 3369
    • Montana
      • Great Falls, Montana, United States, 59405
        • Boeson Research 3367
      • Kalispell, Montana, United States, 59901
        • Boeson Research 3265
      • Missoula, Montana, United States, 59804
        • Boeson Research 3267
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Meridian Clinical Research 3264
      • Hastings, Nebraska, United States, 68901
        • Meridian Clinical Research 3263
      • Lincoln, Nebraska, United States, 68526
        • Alivation Research
      • Lincoln, Nebraska, United States, 68510
        • Meridian Clinical Research 3304
      • Omaha, Nebraska, United States, 68117
        • University of Nebraska Medical Center 3315
      • Omaha, Nebraska, United States, 68131
        • University of Nebraska Medical Center 3314
    • New York
      • Bronx, New York, United States, 10468
        • Advantage Clinical Trials
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research LLC 3313
      • Spartanburg, South Carolina, United States, 29301
        • Tribe Clinical Research LLC 3382
      • Summerville, South Carolina, United States, 29486
        • Coastal Pediatric Research
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group 3301
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group 3046
      • Memphis, Tennessee, United States, 38115
        • AVIATI Healthcare & Clinical Research
    • Texas
      • Dallas, Texas, United States, 75230
        • Javara Inc. 3377
      • League City, Texas, United States, 77573
        • Maximos Ob/Gyn
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc
    • Washington
      • Spokane, Washington, United States, 99202
        • Multicare Health System - Rockwood Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Feeding Group
Milk based product
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
Experimental: Experimental Feeding Group
Milk based product with oligosaccharides
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 Reference Group
Human Milk
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: Study Day 1 to 6 Months of Age
weight for age z-score
Study Day 1 to 6 Months of Age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of respiratory infection between study groups
Time Frame: Study Day 1 to 24 Months of Age
Adverse event reports
Study Day 1 to 24 Months of Age
Number of respiratory infection episodes between study groups
Time Frame: Study Day 1 to 24 Months of Age
Adverse event reports
Study Day 1 to 24 Months of Age
Incidence of infection morbidity between study groups
Time Frame: Study Day 1 to 24 Months of Age
Adverse event reports
Study Day 1 to 24 Months of Age
Number of episodes of infection morbidity between study groups
Time Frame: Study Day 1 to 24 Months of Age
Adverse event reports
Study Day 1 to 24 Months of Age
Weight
Time Frame: Study Day 1 to 24 Months of Age
Interval weight gain per day
Study Day 1 to 24 Months of Age
Length
Time Frame: Study Day 1 to 24 Months of Age
Interval length gain per day
Study Day 1 to 24 Months of Age
Head Circumference
Time Frame: Study Day 1 to 24 Months of Age
Interval head circumference gain per day
Study Day 1 to 24 Months of Age
Gastrointestinal Tolerance
Time Frame: Study Day 1 to 12 months of Age
Parent completed diary
Study Day 1 to 12 months of Age

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Formula Satisfaction Questionnaire
Time Frame: 28 Days of Age to 6 Months of Age
Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative
28 Days of Age to 6 Months of Age
Toddler Drink Satisfaction Questionnaire
Time Frame: 18 Months of Age to 24 Months of Age
Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative
18 Months of Age to 24 Months of Age
Infant Feeding and Stool Patterns Questionnaire
Time Frame: 28 Days of Age to 119 Days of Age]
Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from Always to Never
28 Days of Age to 119 Days of Age]
Infant and Toddler Behavior Questionnaire
Time Frame: 119 Days of Age
Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled from Always to Never
119 Days of Age
Product Intake
Time Frame: Study Day 1 to 24 Months of Age
Parent completed intake diary
Study Day 1 to 24 Months of Age
Dietary Intake
Time Frame: 6 Months of Age to 24 Months of Age
Parent completed 24-hour recall
6 Months of Age to 24 Months of Age
Stool Sample
Time Frame: Study Day 1 to 24 Months of Age
Microbiota characterization; Subset of subjects
Study Day 1 to 24 Months of Age
Bayley™-4 Scale of Infant & Toddler Development IV
Time Frame: 12 Months of Age to 24 Months of Age
Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups; Subset of subjects
12 Months of Age to 24 Months of Age
MacArthur Communicative Developmental Inventory (CDI)/Words and Gestures and CDI)/Words and Sentences
Time Frame: 12 Months of Age to 24 Months of Age
Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups
12 Months of Age to 24 Months of Age
Modified Home Short Form
Time Frame: 6 Months of Age to 24 Months of Age]
Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups
6 Months of Age to 24 Months of Age]
Medications
Time Frame: Study Day 1 to 24 Months of Age
Medication usage including frequency and reason for use
Study Day 1 to 24 Months of Age
Adverse Events
Time Frame: Study Day 1 to 24 Months of Age
Parent reported adverse events
Study Day 1 to 24 Months of Age
Health Resource Utilization
Time Frame: Study Day 1 to 24 Months of Age
Number of visits
Study Day 1 to 24 Months of Age
Missed Parental Work Days
Time Frame: Study Day 1 to 24 Months of Age
Parent reported number of days
Study Day 1 to 24 Months of Age
Blood Collection
Time Frame: 6 and 24 Months of Age
Blood Immune Markers; Subset of subjects
6 and 24 Months of Age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elizabeth Reverri, PhD, MS, RD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AL51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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