Growth of Infants Fed New Starter Formula

Study Overview
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Brief Summary
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The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.

Detailed Description
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Breastfeeding represents the gold standard for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk. The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.

Official Title
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Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics

Conditions
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Dietary Intervention

Intervention / Treatment
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* Other: test starter infant formula
* Other: test starter infant formula with synbiotics
* Other: control standard formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy newborn infant Full-term (> 37 weeks gestation) Birth weight > 2500 and < 4500 g 14±3 days of age on enrollment Singleton birth Infant's mother has elected not to breastfeed prior to enrollment Has not received solid foods Having obtained his/her legal representative's informed consent Exclusion Criteria: Known or suspected cow-milk allergy Congenital illness or malformation that may affect infant feeding and/or growth Significant prenatal and/or postnatal disease Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements Has received oral or intravenous antibiotic therapy in the last 7 days Has received probiotics in the last 7 days Currently participating in another clinical study Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)

Ages Eligible for Study
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Minimum Age: 11 Days
Maximum Age: 6 Months

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: standard starter infant formula<br>standard starter infant formula | Other: control standard formula<br>* infant are fed 6 months with this formula<br>|
| Experimental: test starter formula<br>test infant formula | Other: test starter infant formula<br>* infants are fed for 6 months with this starter formula<br>|
| Experimental: test starter formula with synbiotics<br>starter formula with synbiotics and adapted protein levels | Other: test starter infant formula with synbiotics<br>* infant are fed for 6 months with this formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance, morbidity, protein status, metabolic markers |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, synbiotics, probiotics, nutrition