Focus on Healthy Infant Growth.
Conditions
Keywords
Infant formula, Probiotic microorganisms, prebiotic
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
Interventions
DIETARY_SUPPLEMENTInfant Formula
Sponsors
Materna Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 21 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight gain | 1 to 120 days of age |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric | 1-120 days of age |
| GI tolerance | 1-120 days of age |
Other
| Measure | Time frame | Description |
|---|---|---|
| Influence on the microbial content of the stool | 3 - 4 times: 1-16 d, 4 w 16 w and 36 w | Stool were collected to analyze the microbial content of certain bacteria upon enrollment and at the age of 4, 16. and 36 w Stool were collected and delivery to the lab in coolers within 12 h |
Countries
Israel
Outcome results
None listed