Status:
COMPLETED
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
Lead Sponsor:
Société des Produits Nestlé (SPN)
Collaborating Sponsors:
Puerta de Hierro University Hospital
University of Navarrra Hospital (Clinica Universitaria)
Conditions:
Growth
Tolerance
Eligibility:
All Genders
7-2 years
Phase:
NA
Brief Summary
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two publis...
Detailed Description
Objectives: The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a rea...
Eligibility Criteria
Inclusion
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- Parent(s) are willing and able to fulfill the requirements of the study protocol
- Healthy full term (37-42 weeks gestation) infant
- Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- Parent(s) must have independently elected, before enrollment, to formula feed
Exclusion
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- Parent(s) are willing and able to fulfill the requirements of the study protocol
- Healthy full term (37-42 weeks gestation) infant
- Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04055363
Start Date
October 1 2018
End Date
December 31 2018
Last Update
August 13 2019
Active Locations (6)
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1
Vitha Santa Catalina Hospital
Las Palmas de Gran Canaria, Canary Islands, Spain, 35005
2
Hospital Maternal MH Belén
A Coruña, Galicia, Spain, 15011
3
Universitary Hospital Quirón-Dexeus
Barcelona, Spain, 08028
4
Ruber Internacional Clinic
Madrid, Spain, 28034