Status:
COMPLETED
Synbiotics and Growth
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infants Growth
Eligibility:
All Genders
Up to 14 years
Phase:
PHASE3
Brief Summary
The primary objective of the trial is to assess the growth of the infants enrolled into the study. Other parameters to be measured include microbiota balance and certain blood biochemical values. In a...
Detailed Description
The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. Th...
Eligibility Criteria
Inclusion
- Healthy new-born infant
- Infant is less14 days old on day of enrollment
- Birthweight between 2500g and 4500g
- Gestational age over 37 weeks
- Singleton birth
- Infant's mother, before the 14th day of the child's life, has elected not to breastfeed
- Infant randomized in to a treatment group can expected to be exclusively fed the formula from enrolment until 16 weeks old
- Having obtained his/her legal representative's informed consent
Exclusion
- Currently participating in another clinical trial
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
- Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
- Receiving antibiotic treatment at time of enrolment or in the 5 previous days.
- Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01886898
Start Date
June 1 2007
End Date
October 1 2009
Last Update
June 26 2013
Active Locations (1)
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1
Istituto di Ostetricia e Genecologia
Palermo, Italy, 90127