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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Nutribén Innova® 1; Dietary supplement: Nutribén®; Dietary supplement: Breastfeed

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Cap Montclar
  • Barcelona, Spain
    • Cap Nova Lloreda
  • Barcelona, Spain
    • Cap Sant Ildefons
  • Barcelona, Spain
    • Consulta Dr. Xavier Riopedre
  • Madrid, 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
    • Cs La Rivota
  • Madrid, Spain
    • Cs Las Américas
  • Madrid, Spain
    • Cs Miguel Servet
  • Madrid, Spain
    • Cs Parque Loranca
  • Madrid, Spain
    • Cs Presentación Sabio
  • Madrid, Spain
    • Cs Valle de La Oliva
  • Sevilla, Spain
    • Clínica Dr Aguilar-Dr Sacristán
  • Sevilla, Spain
    • Consultas Externas Hospital Privado Santa Ángela de La Cruz
  • Sevilla, Spain
    • Cs Amante Laffón
  • Sevilla, Spain
    • Cs Utrera Norte
  • Sevilla, Spain
    • Ihp Bellavista

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 3 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study Infant Formula; Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria	Dietary supplement: 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
ACTIVE_COMPARATOR: Infant Formula; Infant formula	Dietary supplement: Nutribén®; 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.
ACTIVE_COMPARATOR: Breastfeed Active comparator; Infants who are breastfed	Dietary supplement: Breastfeed; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alter Farmacia, S.A.
• Collaborators: Biopolis S.L.; Fundación Teófilo Hernando, Spain

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 11, 2019
• Primary Completion (ACTUAL): November 25, 2020
• Study Completion (ACTUAL): November 25, 2020

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (ACTUAL): March 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Infant formula, body composition, safety
• Other Study ID Numbers: INNOVA 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No