Impact of Infant Formula on Caregiver-perceived Intolerance

Conditions:Healthy Studies
Therapuetic Areas:Other
Age Range:Any
Start Date:September 24, 2018
End Date:February 1, 2019
Contact:Laura Czerkies

Use our guide to learn which trials are right for you!

Understand the impact of switching to a commercially available infant formula on
gastrointestinal symptoms

Inclusion Criteria:

- Healthy infant

- Full-term (> 37 weeks gestation)

- Birth weight > 2500 and < 4500 g

- 14-60 days of age on enrollment

- Singleton birth

- Infant's mother has elected not to breastfeed prior to enrollment

- Infant exclusively formula-fed for at least 5 days prior to enrollment

- Caregiver perceives infant as very or extremely fussy according to perceived fussiness
based on the previous 3 days

- Caregiver wishes to switch infant's formula

- Has not received solid foods

- Having obtained his/her legal representative's informed consent

Exclusion Criteria:

- Known or suspected cow-milk allergy

- Currently receiving a specialty infant formula (e.g. thickened, extensively
hydrolyzed, amino acid-based, metabolic)

- Has switched formula more than two times since hospital discharge

- Currently experiencing gastrointestinal or respiratory symptoms secondary to an
ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory
infection, flu)

- Congenital illness or malformation that may affect infant feeding and/or growth

- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment

- Receiving probiotic supplements

- Infant's family who in the Investigator's assessment cannot be expected to comply with
treatment (feeding regimen).

- Participation in another study that has not been approved as a concomitant study by
Nestlé Nutrition.
We found this trial at
Owensboro, Kentucky 43201
Principal Investigator: Carroll Howard, MD
Owensboro, KY
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2051 Charlie Hall Boulevard
Charleston, South Carolina 29414
Principal Investigator: Kelli Johnston, MD
Phone: 843-518-5642
Charleston, SC
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Dayton, Ohio 45414
Principal Investigator: Julie Shepard, MD
Phone: 937-424-9294
Dayton, OH
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Layton, Utah 84041
Principal Investigator: Adam Hutchinson, MD
Phone: 801-773-4840
Layton, UT
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1707 Bender Road
Memphis, Tennessee 38116
Principal Investigator: James Carter, MD
Phone: 901-396-8436
Memphis, TN
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Norwich, Connecticut 06360
Principal Investigator: Richard Geller, MD
Norwich, CT
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Waxahachie, Texas 75165
Principal Investigator: Peggy Linguist, MD
Waxahachie, TX
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