Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
NCT ID: NCT04006236
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
245 participants
INTERVENTIONAL
2019-08-05
2021-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Experimental Infant Formula
extensively hydrolyzed casein protein
Experimental Infant Formula
Feed Ad Libitum
Control Infant Formula
extensively hydrolyzed casein protein
Control Infant Formula
Feed Ad Libitum
Interventions
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Experimental Infant Formula
Feed Ad Libitum
Control Infant Formula
Feed Ad Libitum
Eligibility Criteria
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Inclusion Criteria
* Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
* 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 nutrition for the duration of the study
* Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization
Exclusion Criteria
* Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
* Participant participates in another study that has not been approved as a concomitant study by AN.
* Participant has an allergy or intolerance to any ingredient in the study product
* Participant has been treated with antibiotics within 1 week prior to enrollment
0 Days
14 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Carlett Ramirez
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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MedPharmics, LLC
Phoenix, Arizona, United States
Watching Over Mothers & Babies
Tucson, Arizona, United States
Paramount Research Solutions
College Park, Georgia, United States
Springs Medical Research
Owensboro, Kentucky, United States
MedPharmics, LLC
Metairie, Louisiana, United States
MedPharmics, LLC
Gulfport, Mississippi, United States
Quality Clinical Research Inc
Omaha, Nebraska, United States
MedPharmics, LLC
Albuquerque, New Mexico, United States
PMG Research of Peidmont Healthcare
Statesville, North Carolina, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States
Institute of Clinical Research, LLC
Mentor, Ohio, United States
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, United States
Children's Hospital
Sioux Falls, South Dakota, United States
Midsouth Center for Clinical Research
Memphis, Tennessee, United States
Ventavia Research Group, Llc
Fort Worth, Texas, United States
Ventavia Research Group
Houston, Texas, United States
Ventavia Research Group, LLC
Plano, Texas, United States
Countries
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Other Identifiers
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AL33
Identifier Type: -
Identifier Source: org_study_id
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