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

Alter Farmacia, S.A.210 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

210

Conditions

Healthy

Interventions

Nutribén Innova® 1

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

Eligibility

Sex: ALLMin age: 15 DaysMax age: 25 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (21)

Cap Montclar

Barcelona, Spain

Cap Nova Lloreda

Barcelona, Spain

Cap Sant Ildefons

Barcelona, Spain

Consulta Dr. Xavier Riopedre

Barcelona, Spain

Consulta Carlos Nuñez de Prado Aparicio

Madrid, Spain

Consultorio Arroyomolinos (Cs Parque Coimbra)

Madrid, Spain

Cs Alcalde Bartolomé Gonzalez Móstoles

Madrid, Spain

Cs Conde de Barcelona

Madrid, Spain

Cs Dr Luengo Rodríguez

Madrid, Spain

Cs Infante Don Luis de Borbón

Madrid, Spain

...and 11 more locations

Outcomes

Primary Outcomes

Weight gain at 6 months

Measure of weight gain by grams/day between the first visit and month 6

Time frame: 6 months after the beginning of the study

Secondary Outcomes

weight at 21 days, 2, 4, 6 and 12 months

Measure of weight gain by grams

Time frame: 21 days, 2, 4, 6 and 12 months

Length gain

Measure of the infant's length gain over time in cms

Time frame: 21 days, 2, 4, 6 and 12 months

Head circumference gain

Measure of the increase of the head circumference over time in cms

Time frame: 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

Time frame: 4, 6 and 12 months

Subscapular skin fold develompent

Measurement of the development of subscapular skin fold, in cms, measured using a skinfold caliper

Time frame: 4, 6 and 12 months

Mean arm circumference

Measure of arm circumference over time in cms.

Time frame: 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.

Time frame: 21 days, 2, 4, 6 and 12 months

Feces features number of bowel movements

Number of bowel movements per day sorted by study group

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 4, 6 and 12 months

Evolution of calprotectin levels in feces

Measurement of the evolution of calprotectin levels in feces over time

Time frame: 21 days, 2, 6 and 12 months

Evolution of IgA levels in feces

Measurement of the evolution of IgA levels in feces over time

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 2, 4, 6 and 12 months