Effect of Formula on Infant Behavior
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 7/22/2016 |
Start Date: | April 2016 |
End Date: | September 2016 |
Contact: | Kristen DeLuca |
Email: | kristen.deluca@abbott.com |
Phone: | 614-624-5455 |
Effect of Formula Supplemented With Oligosaccharides on Infant Behavior
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula
intolerance in healthy term infants.
intolerance in healthy term infants.
Inclusion Criteria:
- Subject is in good health as determined from subject's medical history by parent
report
- Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
- Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- Subject is between 7 and 42 days of age
- Infant was identified by parents as very fussy or extremely fussy in the baseline
tolerance evaluation
- Infant is exclusively formula-fed at time of study entry
- Parent(s) confirm their intention not to administer vitamin or mineral supplements,
solid foods or juices to their infant from enrollment through the duration of the
study
- Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF)
prior to any participation in the study
Exclusion Criteria:
- An adverse maternal, fetal or subject medical history that has potential for effects
on tolerance, growth, and/or development
- Subject is taking and plans to continue medications, home remedies, herbal
preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Subject participates in another study that has not been approved as a concomitant
study
- Subject has been fed any formula containing human milk oligosaccharides prior to
study enrollment
- Subject has been treated with oral antibiotics within 7 days prior to study
enrollment
- Mother intends to use a combination of breast and formula feeding
We found this trial at
14
sites
Orlando, Florida 32822
Principal Investigator: Humberto Cruz, DO
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707 Hollybrook Drive
Longview, Texas 75605
Longview, Texas 75605
903-238-8854
Principal Investigator: Cynthia C Somers, MD
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Birmingham, Alabama 35235
Principal Investigator: William H Johnston, MD
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Charleston, South Carolina 29414
Principal Investigator: Robert A Clifford, MD
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Dothan, Alabama 36305
Principal Investigator: Claude T Ashley, Jr., M.D., Ph.D.
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Lincoln, Nebraska 68504
Principal Investigator: Paul D Bernhardson, MD
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Saint Petersburg, Florida 33710
Principal Investigator: Jeffrey A Hirschfield, MD
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San Antonio, Texas 78229
Principal Investigator: Tina H Boylston, MD
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