Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.

Not Applicable

• Conditions: Focus on Healthy Infant Growth.
• Interventions: Dietary Supplement: Infant Formula

• Registration Number: NCT00836771
• Lead Sponsor: Materna Laboratories

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 compare with an otherwise identical widely used commercially available milk based infant formula and/or breast feed

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Study Start: 2009-07
• Status Verified: 2012-05
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31
• Primary Completion: 2014-01
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Materna infant formula 1	Infant Formula	milk based infant formula powder
Materna infant formula 2	Infant Formula	Probiotic supplemented infant formula
Materna infant formula 3	Infant Formula	Prebiotic supplemented infant formula
Materna infant formula 4	Infant Formula	Prebiotic+ Probiotic supplemented infant formula
Human milk	Infant Formula	Human Milk

Primary Outcome Measures

Name	Time	Method
weight gain	1 to 120 days of age

Secondary Outcome Measures

Name	Time	Method
Anthropometric	1-120 days of age
GI tolerance	1-120 days of age

Trial Locations

Locations (1)

Neonatology department, Laniado Hospital- Sanz Medical Center, .; 🇮🇱 Netanya,, Israel