GrowthNCT04957992
BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)
A study testing Experimental Infant Formula, Experimental Toddler Drink and Human Milk in people with Growth, run by Abbott Nutrition at 42 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Experimental Infant Formula, Experimental Toddler Drink and Human Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 42 sitesUnited States
- Study dates
- 21 Jul 2021to 12 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
TOPAZ Clinical Research, Inc.
Apopka, Florida, 32703
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Holston Medical Group 3301
Bristol, Tennessee, 37620
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, 80922
MedPharmics, LLC 3343
Covington, Louisiana, 70433
Javara Inc. 3377
Dallas, Texas, 75230
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Qualmedica Research
Evansville, Indiana, 47715
Deaconess Clinic, Inc.
Evansville, Indiana, 47725
HealthStar Research
Glenwood, Arkansas, 71943
Meridian Clinical Research 3264
Grand Island, Nebraska, 68803
Boeson Research 3266
Grand Junction, Colorado, 81505
Boeson Research 3367
Great Falls, Montana, 59405
Tribe Clinical Research LLC 3313
Greenville, South Carolina, 29607
Meridian Clinical Research 3263
Hastings, Nebraska, 68901
HealthStar Research, LLC
Hot Springs, Arkansas, 71913
Clinical Research Prime
Idaho Falls, Idaho, 83404
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Boeson Research 3265
Kalispell, Montana, 59901
Holston Medical Group 3046
Kingsport, Tennessee, 37660
Maximos Ob/Gyn
League City, Texas, 77573
Meridian Clinical Research 3304
Lincoln, Nebraska, 68510
Alivation Research
Lincoln, Nebraska, 68526
Applied Research Center of Arkansas
Little Rock, Arkansas, 72019
Meridian Clinical Research 3259
Macon, Georgia, 31210
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, 38115
Columbus Clinical Services, LLC.
Miami, Florida, 33125
Boeson Research 3267
Missoula, Montana, 59804
University of Nebraska Medical Center 3315
Omaha, Nebraska, 68117
University of Nebraska Medical Center 3314
Omaha, Nebraska, 68131
Qualmedica Research, LLC
Owensboro, Kentucky, 42301
Emerald Coast OBGYN Clinical Research
Panama City, Florida, 32405
MedPharmics, LLC 3192
Phoenix, Arizona, 85015
National Clinical Research, Inc
Richmond, Virginia, 23294
MedPharmics Research 3369
Slidell, Louisiana, 70458
Tribe Clinical Research LLC 3382
Spartanburg, South Carolina, 29301
Multicare Health System - Rockwood Pediatrics
Spokane, Washington, 99202
ASCLEPES Research Centers
Spring Hill, Florida, 34609
Coastal Pediatric Research
Summerville, South Carolina, 29486
Jedidiah Clinical Research
Tampa, Florida, 33617
Advantage Clinical Trials
The Bronx, New York, 10468
About this study
Official title: 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.
- Conditions
- Growth
- Being tested
- Control Infant Formula, Control Toddler Drink, Experimental Infant Formula, Experimental Toddler Drink, Human Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Infant FormulaOther
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Control Toddler DrinkOther
~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Experimental Infant FormulaOther
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Experimental Toddler DrinkOther
~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Human MilkOther
Ad libitum or as instructed by HCP
Human Milk Supplemental FormulaOther
Ad libitum if consuming supplemented formula; feeding period up to 12 months of age
Human Milk Toddler DrinkOther
~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age
| Study group | Role | What they receive |
|---|---|---|
| Control Feeding Group | Active comparator | Milk based product Receives: Other: Control Infant Formula; Other: Control Toddler Drink |
| Experimental Feeding Group | Experimental | Milk based product with oligosaccharides Receives: Other: Experimental Infant Formula; Other: Experimental Toddler Drink |
| Human Milk Reference Group | Other | Human Milk Receives: Other: Human Milk; Other: Human Milk Supplemental Formula; Other: Human Milk Toddler Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
weight for age z-score
Measured: Study Day 1 to 6 Months of Age
Secondary outcomes (8)
Incidence of respiratory infection between study groups
Adverse event reports
Measured: Study Day 1 to 24 Months of Age
Number of respiratory infection episodes between study groups
Adverse event reports
Measured: Study Day 1 to 24 Months of Age
Incidence of infection morbidity between study groups
Adverse event reports
Measured: Study Day 1 to 24 Months of Age
Number of episodes of infection morbidity between study groups
Adverse event reports
Measured: Study Day 1 to 24 Months of Age
Weight
Interval weight gain per day
Measured: Study Day 1 to 24 Months of Age
Length
Interval length gain per day
Measured: Study Day 1 to 24 Months of Age
Head Circumference
Interval head circumference gain per day
Measured: Study Day 1 to 24 Months of Age
Gastrointestinal Tolerance
Parent completed diary
Measured: Study Day 1 to 12 months of Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start21 Jul 2021
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Reverri, PhD, MS, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957992
- Sponsor's protocol ID
- AL51
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
- ClinicalTrials.gov ID
- NCT04957992
- Acronym / sponsor ID
- AL51
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Feeding Group | Active comparator | Other: Control Infant Formula, Other: Control Toddler DrinkMilk based product |
| Experimental Feeding Group | Experimental | Other: Experimental Infant Formula, Other: Experimental Toddler DrinkMilk based product with oligosaccharides |
| Human Milk Reference Group | Other | Other: Human Milk, Other: Human Milk Supplemental Formula, Other: Human Milk Toddler DrinkHuman Milk |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Infant FormulaAd libitum or as instructed by HCP, feeding period from enrollment to 12 months of age | Other | Control Feeding Group |
| Control Toddler Drink~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age | Other | Control Feeding Group |
| Experimental Infant FormulaAd libitum or as instructed by HCP, feeding period from enrollment to 12 months of age | Other | Experimental Feeding Group |
| Experimental Toddler Drink~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age | Other | Experimental Feeding Group |
| Human MilkAd libitum or as instructed by HCP | Other | Human Milk Reference Group |
| Human Milk Supplemental FormulaAd libitum if consuming supplemented formula; feeding period up to 12 months of age | Other | Human Milk Reference Group |
| 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 | Other | Human Milk Reference Group |
Primary outcome
Growth
Time frame: Study Day 1 to 6 Months of Age
weight for age z-score
8 secondary outcomes
Incidence of respiratory infection between study groups
Time frame: 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
Incidence of infection morbidity between study groups
Time frame: 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
Weight
Time frame: Study Day 1 to 24 Months of Age
Length
Time frame: Study Day 1 to 24 Months of Age
Head Circumference
Time frame: Study Day 1 to 24 Months of Age
Gastrointestinal Tolerance
Time frame: Study Day 1 to 12 months of Age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Growth
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Reverri, PhD, MS, RD study chair
Abbott Nutrition
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula, Experimental Toddler Drink and Human Milk in people with Growth, run by Abbott Nutrition at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: Study Day 1 to 6 Months of Age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.