Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Nutribén®Dietary Supplement: BreastfeedDietary Supplement: Nutribén Innova® 1
- Registration Number
- NCT05303077
- Lead Sponsor
- Alter Farmacia, S.A.
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infant Formula Nutribén® Infant formula Breastfeed Active comparator Breastfeed Infants who are breastfed Study Infant Formula Nutribén Innova® 1 Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria
- Primary Outcome Measures
Name Time Method Weight gain at 6 months 6 months after the beginning of the study Measure of weight gain by grams/day between the first visit and month 6
- Secondary Outcome Measures
Name Time Method weight at 21 days, 2, 4, 6 and 12 months 21 days, 2, 4, 6 and 12 months Measure of weight gain by grams
Length gain 21 days, 2, 4, 6 and 12 months Measure of the infant's length gain over time in cms
Head circumference gain 21 days, 2, 4, 6 and 12 months Measure of the increase of the head circumference over time in cms
Feces features consistency 21 days, 2, 4, 6 and 12 months 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.
Evolution of calprotectin levels in feces 21 days, 2, 6 and 12 months Measurement of the evolution of calprotectin levels in feces over time
Evolution of IgA levels in feces 21 days, 2, 6 and 12 months Measurement of the evolution of IgA levels in feces over time
Evolution lactic acid levels in feces 21 days, 2, 6 and 12 months Measurement of the evolution of lactic acid levels in feces over time
Overall rate of the products 2, 4, 6 and 12 months Quantitative variable. The parents' subjective rate of the products. The assessment can be, acceptable, good, very good, satisfactory or not satisfactory.
Mean arm circumference 4, 6 and 12 months Measure of arm circumference over time in cms.
Feces features number of bowel movements 21 days, 2, 4, 6 and 12 months Number of bowel movements per day sorted by study group
Digestive tolerance 4, 6 and 12 months 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.
intestinal microbiota 4, 6 and 12 months 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.
Infant's behavior 4, 6 and 12 months 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.
Evolution of short-chain fatty acid levels in feces 21 days, 2, 6 and 12 months Measurement of the evolution of short-chain fatty acid levels in feces over time
Morbility over a year Analysis of the number and frequency of all adverse events registered during the study by feeding group
Products Tolerability over a year 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.
Tricipital Skin fold development 4, 6 and 12 months Measurement of the development of tricipital skin fold, in cms, measured using a skinfold caliper
Subscapular skin fold develompent 4, 6 and 12 months Measurement of the development of subscapular skin fold, in cms, measured using a skinfold caliper
Trial Locations
- Locations (21)
Cs Amante Laffón
🇪🇸Sevilla, Spain
Cap Montclar
🇪🇸Barcelona, Spain
Cap Nova Lloreda
🇪🇸Barcelona, Spain
Consultorio Arroyomolinos (Cs Parque Coimbra)
🇪🇸Madrid, Spain
Cap Sant Ildefons
🇪🇸Barcelona, Spain
Consulta Dr. Xavier Riopedre
🇪🇸Barcelona, Spain
Consulta Carlos Nuñez de Prado Aparicio
🇪🇸Madrid, Spain
Cs Alcalde Bartolomé Gonzalez Móstoles
🇪🇸Madrid, Spain
Cs Dr Luengo Rodríguez
🇪🇸Madrid, Spain
Cs Infante Don Luis de Borbón
🇪🇸Madrid, Spain
Consultas Externas Hospital Privado Santa Ángela de La Cruz
🇪🇸Sevilla, Spain
Cs Miguel Servet
🇪🇸Madrid, Spain
Cs Conde de Barcelona
🇪🇸Madrid, Spain
Cs Presentación Sabio
🇪🇸Madrid, Spain
Cs La Rivota
🇪🇸Madrid, Spain
Cs Las Américas
🇪🇸Madrid, Spain
Cs Parque Loranca
🇪🇸Madrid, Spain
Cs Valle de La Oliva
🇪🇸Madrid, Spain
Clínica Dr Aguilar-Dr Sacristán
🇪🇸Sevilla, Spain
Cs Utrera Norte
🇪🇸Sevilla, Spain
Ihp Bellavista
🇪🇸Sevilla, Spain