Impact of Infant Formula on Caregiver-perceived Intolerance
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 12/9/2018 |
Start Date: | September 24, 2018 |
End Date: | February 1, 2019 |
Contact: | Laura Czerkies |
Email: | laura.czerkies@us.nestle.com |
Phone: | 815-630-5223 |
Understand the impact of switching to a commercially available infant formula on
gastrointestinal symptoms
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
7
sites
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2051 Charlie Hall Boulevard
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Principal Investigator: Kelli Johnston, MD
Phone: 843-518-5642
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Dayton, Ohio 45414
Principal Investigator: Julie Shepard, MD
Phone: 937-424-9294
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1707 Bender Road
Memphis, Tennessee 38116
Memphis, Tennessee 38116
Principal Investigator: James Carter, MD
Phone: 901-396-8436
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