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
1707 Bender Road
Memphis, Tennessee 38116
Memphis, Tennessee 38116
Principal Investigator: James Carter, MD
Phone: 901-396-8436
Click here to add this to my saved trials
2051 Charlie Hall Boulevard
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Principal Investigator: Kelli Johnston, MD
Phone: 843-518-5642
Click here to add this to my saved trials
Dayton, Ohio 45414
Principal Investigator: Julie Shepard, MD
Phone: 937-424-9294
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials