Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants

Study Overview
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Brief Summary
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This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and tolerability of the investigational products (measured as number, frequency and severity of adverse events in all branches of the study)

Official Title
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The Effect of a New Newborn Formula Over the Corporal Composition: a Randomized Multicentric Clinical Trial

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Nutribén Innova® 1
* Dietary Supplement: Nutribén®
* Dietary Supplement: Breastfeed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children. Both sex. Full term infants (between 37 and 42 weeks of pregnancy). Birth weight between 2500 g- 4500 g. Single birth babies. BMI of the mothers before the pregnancy between 19 y 30 kg/m2. Exclusion Criteria: Body weight lower than the 5th percentile for their gestational age. Cow's milk protein allergy and/or lactose allergy. Administration of antibiotics 7 days prior inclusion. Congenital disease or malformation that may affect the infant growth rate. Population Description: The study population are newborns selected from primary care clinics in Spain. Sampling Method: Not applicable Metabolic disease or disorders. Significant prenatal disease and/or serious postnatal disease before recruitment. Underage parents. Diabetic mother. Born from a drug abuse mother (who use abuse drugs during pregnancy). Parents cannot comply with study procedures. Subject included or that have been included in other clinical trial since his/her birth day.

Ages Eligible for Study
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Minimum Age: 15 Days
Maximum Age: 25 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Infant Formula<br>Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria | Dietary Supplement: Nutribén Innova® 1<br>* Infants are fed solely with infant formula supplemented with an inactive probiotic and omega 3 fatty acids over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's<br>|
| Active Comparator: Infant Formula<br>Infant formula | Dietary Supplement: Nutribén®<br>* Infants are fed solely with infant formula over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's age.<br>|
| Active Comparator: Breastfeed Active comparator<br>Infants who are breastfed | Dietary Supplement: Breastfeed<br>* Infants are breastfeeding solely over the first 6 months of their life, from then on the infants are fed as recommended by their caregiver, as if they are not participating in a research study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain at 6 months | Measure of weight gain by grams/day between the first visit and month 6 | 6 months after the beginning of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight at 21 days, 2, 4, 6 and 12 months | Measure of weight gain by grams | 21 days, 2, 4, 6 and 12 months | 
| Length gain | Measure of the infant's length gain over time in cms | 21 days, 2, 4, 6 and 12 months | 
| Head circumference gain | Measure of the increase of the head circumference over time in cms | 21 days, 2, 4, 6 and 12 months | 
| Tricipital Skin fold development | Measurement of the development of tricipital skin fold, in cms, measured using a skinfold caliper | 4, 6 and 12 months | 
| Subscapular skin fold develompent | Measurement of the development of subscapular skin fold, in cms, measured using a skinfold caliper | 4, 6 and 12 months | 
| Mean arm circumference | Measure of arm circumference over time in cms. | 4, 6 and 12 months | 
| Feces features consistency | Description of the consistency of baby's feces features, according to their parent's perception, on a qualitative scale: soft, hard, liquid, normal, semiliquid, pasty. The analysis includes the number of feces in each group and the overall frequency by study arm and visit. | 21 days, 2, 4, 6 and 12 months | 
| Feces features number of bowel movements | Number of bowel movements per day sorted by study group | 21 days, 2, 4, 6 and 12 months | 
| Digestive tolerance | The digestive tolerance will be assessed as adequate, constipation, flatulence, vomit or other distresses, which are a heterogeneous group that includes various affections as diarrhea, abdominal pain, irritability, constipation, regurgitation or colic. The analysis includes the overall number and the frequency sorted by study arm. | 4, 6 and 12 months | 
| Infant's behavior | Qualitative variable. The infant's behavior is classified as either good or altered. The total number and the relative frequency by group are included in the analysis. | 4, 6 and 12 months | 
| intestinal microbiota | Analysis of the evolution of the intestinal microbiota of the children over the study. The richness and diversity of the microbiota are analyzed and compared between the study groups. | 4, 6 and 12 months | 
| Evolution of calprotectin levels in feces | Measurement of the evolution of calprotectin levels in feces over time | 21 days, 2, 6 and 12 months | 
| Evolution of IgA levels in feces | Measurement of the evolution of IgA levels in feces over time | 21 days, 2, 6 and 12 months | 
| Evolution lactic acid levels in feces | Measurement of the evolution of lactic acid levels in feces over time | 21 days, 2, 6 and 12 months | 
| Evolution of short-chain fatty acid levels in feces | Measurement of the evolution of short-chain fatty acid levels in feces over time | 21 days, 2, 6 and 12 months | 
| Morbility | Analysis of the number and frequency of all adverse events registered during the study by feeding group | over a year | 
| Products Tolerability | Quantitative variable. The tolerability of the products is assessed as adequate, good, very good, unsatisfactory. The analysis includes the overall number y and the relative frequency by group. | over a year | 
| Overall rate of the products | Quantitative variable. The parents' subjective rate of the products. The assessment can be, acceptable, good, very good, satisfactory or not satisfactory. | 2, 4, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant formula, body composition, safety