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

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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.


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
Layton, Utah 84041
Principal Investigator: Brent K Eberhard, MD
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Layton, UT
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
Principal Investigator: Cynthia C Somers, MD
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from
Longview, TX
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Birmingham, Alabama 35235
Principal Investigator: William H Johnston, MD
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mi
from
Birmingham, AL
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Charleston, South Carolina 29414
Principal Investigator: Robert A Clifford, MD
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mi
from
Charleston, SC
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Dothan, Alabama 36305
Principal Investigator: Claude T Ashley, Jr., M.D., Ph.D.
?
mi
from
Dothan, AL
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Grove City, Ohio 43123
Principal Investigator: Samir Arora, MD
?
mi
from
Grove City, OH
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Lincoln, Nebraska 68510
Principal Investigator: Svjetlana Dziko, MD
?
mi
from
Lincoln, NE
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Lincoln, Nebraska 68504
Principal Investigator: Paul D Bernhardson, MD
?
mi
from
Lincoln, NE
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Mayfield Heights, Ohio
Principal Investigator: James Guerrieri, MD
?
mi
from
Mayfield Heights, OH
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Norwich, Connecticut 06360
Principal Investigator: Richard W Geller, MD
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mi
from
Norwich, CT
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Orlando, Florida 32822
Principal Investigator: Humberto Cruz, DO
?
mi
from
Orlando, FL
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Saint Petersburg, Florida 33710
Principal Investigator: Jeffrey A Hirschfield, MD
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mi
from
Saint Petersburg, FL
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San Antonio, Texas 78229
Principal Investigator: Tina H Boylston, MD
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mi
from
San Antonio, TX
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Tucson, Arizona
Principal Investigator: Hugh S Miller, MD
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mi
from
Tucson, AZ
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