Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of the Effect of Milk Based Infant Formula Supplemented Either With Probiotic Microorganisms and/or With Prebiotic on the Intestinal Microflora During the First 4 Months of Life of Healthy, Full Term Infants and it's Long Term Effect on Morbidity up to the Age of 9 Months

Conditions
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Focus on Healthy Infant Growth.

Intervention / Treatment
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* Dietary Supplement: Infant Formula


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Materna infant formula 1<br>milk based infant formula powder | Dietary Supplement: Infant Formula<br> <br> * Other names: Materna;|
| Experimental: Materna infant formula 2<br>Probiotic supplemented infant formula | Dietary Supplement: Infant Formula<br> <br> * Other names: Materna;|
| Experimental: Materna infant formula 3<br>Prebiotic supplemented infant formula | Dietary Supplement: Infant Formula<br> <br> * Other names: Materna;|
| Experimental: Materna infant formula 4<br>Prebiotic+ Probiotic supplemented infant formula | Dietary Supplement: Infant Formula<br> <br> * Other names: Materna;|
| Other: Human milk<br>Human Milk | Dietary Supplement: Infant Formula<br> <br> * Other names: Materna;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain |  | 1 to 120 days of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric |  | 1-120 days of age | 
| GI tolerance |  | 1-120 days of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant formula, Probiotic microorganisms, prebiotic