An interventional study of Nutribén Innova® 1 and Nutribén® in Healthy, sponsored by Alter Farmacia, S.A.. Completed at 21 sites in Spain. Open to participants aged 15 Days to 25 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Alter Farmacia, S.A. · Not applicable, Interventional, and Supportive care
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)
This is the only study on the registry with Alter Farmacia, S.A. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Population Description: The study population are newborns selected from primary care clinics in Spain.
Sampling Method: Not applicable
Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria
Dietary Supplement: Nutribén Innova® 1
Infant formula
Dietary Supplement: Nutribén®
Infants who are breastfed
Dietary Supplement: Breastfeed
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
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.
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.
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
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
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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