Status:
TERMINATED
Growth and Tolerance Trial on Infant Formula With HMO
Lead Sponsor:
FrieslandCampina
Conditions:
Healthy Growth
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
Eligibility Criteria
Inclusion
- Gestational age ≥ 37 weeks
- Birth weight ≥ 2500 grams
- No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
- Boys and girls
- Recruited \< 1 month/age
- Being available for follow up until the age of 4 months
- Exclusive formula feeding or exclusive breast feeding at time of recruitment
Exclusion
- Gestational age \<37 weeks
- Birth weight \<2500 grams
- Severe acquired or congenital diseases, mental or physical disorders
- Illness at screening/ inclusion
- Incapability of parents/caregivers to comply with the study protocol
- Received antibiotics within the first month of life
- Not tolerating standard cow's milk based infant formula
- Participation in another clinical trial
- Maternal illicit drug use during pregnancy or post-partum period
- Parent/caregiver does not have a cell phone to use for filling out questionnaires
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2023
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT04066413
Start Date
September 23 2019
End Date
January 26 2023
Last Update
September 28 2023
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3026