Effects of a Synbiotics-containing Starter Formula on Infant Growth

Study Overview
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Brief Summary
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In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.

Detailed Description
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Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender. The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO. Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.

Official Title
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Growth of Infants Consuming Starter Formula Containing Synbiotics

Conditions
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Infant Nutrition

Intervention / Treatment
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* Other: Standard infant formula with prebiotics
* Other: Infant formula with synbiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy newborn infant Age at point of enrolment ≤14 days Birthweight ≥2500g and ≤4500g Full term infant ≥37 weeks gestation and ≤42 weeks gestation Singleton births Having obtained his/her or his/her legal representative's informed consent Exclusion Criteria: Congenital illness or malformation that may affect normal growth Significant pre-natal or post-natal disease Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.) Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment Patient who cannot be expected to comply with treatment Currently participating or having participated in another clinical trial prior to the beginning of this study

Ages Eligible for Study
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Minimum Age: 11 Days
Maximum Age: 17 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: Test formula 1<br>Standard formula with prebiotics | Other: Standard infant formula with prebiotics<br>* From 0-6 months of age. As per standard requirement<br>|
| Experimental: test product<br>Infant formula with synbiotics | Other: Infant formula with synbiotics<br>* From 0-6 months of age as per standard requirement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean weight gain |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| digestive tolerance |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infants, prebiotics, probiotics, safety