MedTrace Logo

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

NCT05303077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-04-07

No results posted yet for this study

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)

Conditions

  • Healthy

Interventions

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

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.

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.

Sponsors & Collaborators

  • Fundación Teófilo Hernando, Spain

    collaborator OTHER

  • Biopolis S.L.

    collaborator INDUSTRY

  • Alter Farmacia, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Days
Max Age
25 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2020-11-25
Completion
2020-11-25

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303077 on ClinicalTrials.gov