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Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s)

NCT04962594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2024-06-13

No results posted yet for this study

Summary

This is a randomized, controlled, multicenter, double-blind study of healthy term infants. The primary objective of the trial is to demonstrate the safety of a a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth of infants randomized to the experimental formula versus the control formula from enrolment to 4 months of age.

Conditions

  • Healthy Infants

Interventions

OTHER

Experimental formulas (EF)

First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months

OTHER

Control formulas (CF)

First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months

OTHER

Breast feeding (BF)

Exclusive breast feeding up to 4 months

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-02
Primary Completion
2023-07-31
Completion
2024-04-04

Countries

  • Belgium
  • France
  • Germany
  • Spain

Study Locations

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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 NCT04962594 on ClinicalTrials.gov