Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.

Materna Laboratories

Status: Unknown

Conditions: Focus on Healthy Infant Growth.

Treatments: Dietary Supplement: Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00836771

80801

Details and patient eligibility

About

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

Enrollment: 270 estimated patients

Sex: All

Ages: 1 to 21 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 5 patient groups, including a placebo group

Materna infant formula 1

Placebo Comparator group

Description:

milk based infant formula powder

Treatment:

Dietary Supplement: Infant Formula

Materna infant formula 2

Experimental group

Description:

Probiotic supplemented infant formula

Treatment:

Dietary Supplement: Infant Formula

Materna infant formula 3

Experimental group

Description:

Prebiotic supplemented infant formula

Treatment:

Dietary Supplement: Infant Formula

Materna infant formula 4

Experimental group

Description:

Prebiotic+ Probiotic supplemented infant formula

Treatment:

Dietary Supplement: Infant Formula

Human milk

Other group

Description:

Human Milk

Treatment:

Dietary Supplement: Infant Formula