Status:
UNKNOWN
Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.
Lead Sponsor:
Materna Laboratories
Conditions:
Focus on Healthy Infant Growth.
Eligibility:
All Genders
1-21 years
Phase:
NA
Brief Summary
Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants...
Eligibility Criteria
Inclusion
- Healthy term infants of both sexes, born in natural labor .
- Single birth.
- Full term infants (born between the 37th and 42nd week of gestation)
- Infants with birth weight \>2500 g.
- Recruitment age will be 0-21 days.
- Infants whose mothers are unable to breast feed or have chosen not to breast feed prior to the study enrollment.
- Infants whose parents have agreed to participate in the study up to the age of 9 months..
- Infants whose parents have agreed to remain exclusively on the same product for 16 weeks of age..
- Infants whose parents have signed the informed consent form.
- Infants whose parents are able to understand the protocol requirements and to fill out the infant's diary and agree to completely fill out the parents' questionnaires during the period Of 9 months
Exclusion
- Twins.
- Premature or low birth weight (\< 2500 g).
- Chromosomal abnormalities or congenital malformation.
- Suffering jaundice which require phototherapy.
- Proven or suspected family history of allergy to cow's milk.
- Having been treated with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00836771
Start Date
July 1 2009
End Date
December 1 2014
Last Update
July 31 2013
Active Locations (1)
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1
Neonatology department, Laniado Hospital- Sanz Medical Center, .
Netanya, Israel