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
424 participants
INTERVENTIONAL
2013-04-30
2014-02-28
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
TRIPLE
Study Groups
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Human Milk
Reference group, breast feeding ad libitum
Human Milk
Feeding ad libitum
Control Formula
Ready to feed infant formula, feed ad libitum
Control Formula
Feeding ad libitum
Experimental Formula 1
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
Experimental Formula 1
Feeding ad libitum
Experimental Formula 2
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
Experimental Formula 2
Feeding ad libitum
Interventions
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Control Formula
Feeding ad libitum
Experimental Formula 1
Feeding ad libitum
Experimental Formula 2
Feeding ad libitum
Human Milk
Feeding ad libitum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Birth weight \> 2490 g (\~5 lbs 8 oz)
* Between 0 and 5 days of age
* Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
* Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
* Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
* No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
Exclusion Criteria
* Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
* Treatment with antibiotics
* Mother intends to use a combination of breast and formula feeding
5 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Williams, MPH
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Dothan, Alabama, United States
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, United States
Clinical Research Advantage/Colorado Springs Health Partners
Colorado Springs, Colorado, United States
Norwich Pediatric Group, PC
Norwich, Connecticut, United States
Atlantic Clinical Research Collaborative
Boynton Beach, Florida, United States
Lake Mary Pediatrics
Orange City, Florida, United States
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States
USF, College of Medicine, Dept of Pediatrics
Tampa, Florida, United States
Southeast Regional Research Group (SERRG)
Columbus, Georgia, United States
PediaResearch, LLC
Evansville, Indiana, United States
Northpoint Pediatrics, LLC
Indianapolis, Indiana, United States
Lafayette Clinical Research
Lafayette, Indiana, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Ohio Pediatric Research Association, Inc
Dayton, Ohio, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
Clinical Trials of America
Eugene, Oregon, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, United States
Sanford Research
Sioux Falls, South Dakota, United States
Tanner Memorial Clinic
Layton, Utah, United States
Rockwood Clinic, PS
Spokane, Washington, United States
Clinical Research Puerto Rico
Guayama, , Puerto Rico
Ponce School of Medicine/ CAIMED Center
Ponce, , Puerto Rico
Countries
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References
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Hill DR, Buck RH. Infants Fed Breastmilk or 2'-FL Supplemented Formula Have Similar Systemic Levels of Microbiota-Derived Secondary Bile Acids. Nutrients. 2023 May 17;15(10):2339. doi: 10.3390/nu15102339.
Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26.
Other Identifiers
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AL06
Identifier Type: -
Identifier Source: org_study_id
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