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Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery

NCT04256356 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-02-18

No results posted yet for this study

Summary

This is a single-center, double-blind, randomized controlled trial, with parallel groups and reference group.

The aim of the study was to investigate the immunity of infant born from caesarian section and fed with formula milk containing fermented matrix a double and triple dosage compare the first part of the trial FERCT15 assuming a dose-effect relationship of the fermented matrix with immune response.

Conditions

  • Innate Immunity

Interventions

DIETARY_SUPPLEMENT

Feeding infants with formula milk with fermented matrix at dosage of 4.6 g per 100g of powder

Infants enrolled were fed either with formula milk with fermented matrix at double dosage or with formula milk with fermented matrix at triple dosage or with standard formula during the first 3 months of life. Breastfed infants were the reference group.

DIETARY_SUPPLEMENT

Feeding infants with formula milk with fermented matrix at dosage of 6.9 g per 100g of powder

Infants enrolled were fed either with formula milk with fermented matrix at double dosage or with formula milk with fermented matrix at triple dosage or with standard formula during the first 3 months of life. Breastfed infants were the reference group.

OTHER

Feeding infants with standard formula milk

Infants enrolled were fed either with formula milk with fermented matrix at double dosage or with formula milk with fermented matrix at triple dosage or with standard formula during the first 3 months of life. Breastfed infants were the reference group.

OTHER

Breastfeeding infants

reference group

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Heinz Italia SpA

    lead INDUSTRY

Principal Investigators

  • Fabio Mosca, prof · NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2021-02-28
Completion
2021-02-28

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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 NCT04256356 on ClinicalTrials.gov