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

A

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

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

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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