Phase
Condition
N/ATreatment
Human Milk
Control Toddler Drink
Experimental Infant Formula
Clinical Study ID
Ages < 14 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is judged to be in good health as determined from participant's medicalhistory
Participant is a singleton from a full-term birth with a gestational age of 37 - 42weeks 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 solesource of feeding from Study Visit 1 to 6 months of age, and as the sole milkbeverage 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 mineralsupplements,(except for vitamin D supplements if instructed by their healthcareprofessional) from enrollment through the duration of the study
Parent(s) confirm their intention not to administer solid foods or juices to theinfant from enrollment through 6 months of age unless recommended by theparticipant'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 inthe study
If parent(s) elect to feed the participant human milk, they confirm that theirinfant was fed human milk since birth and confirm their intention to exclusivelyfeed 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 confirmtheir intention to use the experimental supplemental/weaning formula andexperimental toddler drink as the primary milk beverage.
Exclusion
Exclusion Criteria:
An adverse maternal, fetal or participant medical history that is thought by theinvestigator 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 mightaffect GI tolerance
Participant is in another study that has not been approved as a concomitant study byAN
Participant has been treated with antibiotics (except for topical antibiotics, eyedrops) prior to enrollment
Participant has been treated with other medications (besides antibiotics) that inthe opinion of the PI may affect growth, GI tolerance and/or development, prior toenrollment
Study Design
Connect with a study center
MedPharmics, LLC 3192
Phoenix, Arizona 85015
United StatesSite Not Available
HealthStar Research
Glenwood, Arkansas 71943
United StatesSite Not Available
HealthStar Research, LLC
Hot Springs, Arkansas 71913
United StatesSite Not Available
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas 72401
United StatesSite Not Available
Applied Research Center of Arkansas
Little Rock, Arkansas 72019
United StatesSite Not Available
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado 80922
United StatesSite Not Available
Boeson Research 3266
Grand Junction, Colorado 81505
United StatesSite Not Available
TOPAZ Clinical Research, Inc.
Apopka, Florida 32703
United StatesSite Not Available
Kissimmee Clinical Research
Kissimmee, Florida 34743
United StatesSite Not Available
Columbus Clinical Services, LLC.
Miami, Florida 33125
United StatesSite Not Available
Health and Life Research Institute
Miami, Florida 33155
United StatesSite Not Available
Emerald Coast OBGYN Clinical Research
Panama City, Florida 32405
United StatesSite Not Available
Pensacola Research Consultations Inc.
Pensacola, Florida 32503
United StatesSite Not Available
ASCLEPES Research Centers
Spring Hill, Florida 34609
United StatesSite Not Available
Jedidiah Clinical Research
Tampa, Florida 33617
United StatesSite Not Available
Meridian Clincial Research 3259
Macon, Georgia 31210
United StatesActive - Recruiting
Meridian Clinical Research 3259
Macon, Georgia 31210
United StatesSite Not Available
Clinical Research Prime
Idaho Falls, Idaho 83404
United StatesSite Not Available
Leavitt Clinical Research
Idaho Falls, Idaho 83404
United StatesSite Not Available
Deaconess Clinic, Inc.
Evansville, Indiana 47725
United StatesSite Not Available
Qualmedica Research
Evansville, Indiana 47715
United StatesSite Not Available
Qualmedica Research, LLC
Owensboro, Kentucky 42301
United StatesSite Not Available
Meridian Clinical Research 3080
Baton Rouge, Louisiana 70806
United StatesSite Not Available
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
United StatesSite Not Available
MedPharmics, LLC 3343
Covington, Louisiana 70433
United StatesSite Not Available
MedPharmics, LLC 3081
Metairie, Louisiana 70006
United StatesSite Not Available
MedPharmics Research 3369
Slidell, Louisiana 70458
United StatesSite Not Available
Southern Clinical Research
Zachary, Louisiana 70791
United StatesSite Not Available
Boeson Research 3367
Great Falls, Montana 59405
United StatesSite Not Available
Boeson Research 3265
Kalispell, Montana 59901
United StatesSite Not Available
Boeson Research 3267
Missoula, Montana 59804
United StatesSite Not Available
Meridian Clincial Research 3264
Grand Island, Nebraska 68803
United StatesActive - Recruiting
Meridian Clinical Research 3264
Grand Island, Nebraska 68803
United StatesSite Not Available
Meridian Clinical Research 3263
Hastings, Nebraska 68901
United StatesSite Not Available
Alivation Research
Lincoln, Nebraska 68526
United StatesSite Not Available
Meridian Clinical Research 3304
Lincoln, Nebraska 68510
United StatesSite Not Available
University of Nebraska Medical Center 3314
Omaha, Nebraska 68131
United StatesSite Not Available
University of Nebraska Medical Center 3315
Omaha, Nebraska 68117
United StatesSite Not Available
Med Clinical Research Partners, LLC
Irvington, New Jersey 07111
United StatesSite Not Available
Advantage Clincial Trials
Bronx, New York 10468
United StatesSite Not Available
Advantage Clinical Trials
Bronx, New York 10468
United StatesSite Not Available
Ohio Pediatric Research Association
Dayton, Ohio 45414
United StatesSite Not Available
Tribe Clinical Research LLC 3313
Greenville, South Carolina 29607
United StatesSite Not Available
Tribe Clinical Research LLC 3382
Spartanburg, South Carolina 29301
United StatesSite Not Available
Coastal Pediatric Research
Summerville, South Carolina 29486
United StatesSite Not Available
Holston Medical Group 3301
Bristol, Tennessee 37620
United StatesSite Not Available
Holston Medical Group 3046
Kingsport, Tennessee 37660
United StatesSite Not Available
AVIATI Healthcare & Clinical Research
Memphis, Tennessee 38115
United StatesSite Not Available
Javara Inc. 3377
Dallas, Texas 75230
United StatesSite Not Available
Maximos Ob/Gyn
League City, Texas 77573
United StatesSite Not Available
AIH Research
Pearland, Texas 77584
United StatesSite Not Available
National Clinical Research, Inc
Richmond, Virginia 23294
United StatesSite Not Available
Multicare Health System - Rockwood Pediatrics
Spokane, Washington 99202
United StatesSite Not Available
Multicare Health System- Rockwood Pediatrics
Spokane, Washington 99202
United StatesTerminated
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