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

Alter Farmacia

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Nutribén®; Dietary Supplement: Nutribén Innova® 1; Dietary Supplement: Breastfeed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05303077

INNOVA 2020

Details and patient eligibility

About

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)

Enrollment: 210 patients

Sex: All

Ages: 15 to 25 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups

Study Infant Formula

Experimental group

Description:

Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria

Treatment:

Dietary Supplement: Nutribén Innova® 1

Infant Formula

Active Comparator group

Description:

Infant formula

Treatment:

Dietary Supplement: Nutribén®

Breastfeed Active comparator

Active Comparator group

Description:

Infants who are breastfed

Treatment:

Dietary Supplement: Breastfeed