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

NCT03637894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2018-08-20

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 whether feed a fermented formula milk leads to an increase of anti-microbial peptides such as catelecidine, alpha and beta defensins and secretory-IgA, compared to feed a standard formula (Plasmon Primigiorni), according to mode of delivery. Breastfed infants were the reference group.

Conditions

  • Innate Immunity
  • Newborns
  • Nutrition
  • Microbiota

Interventions

DIETARY_SUPPLEMENT

Feeding infants with fermented formula milk

Infants enrolled were fed either with fermented formula milk or with standard formula during the first four months of life. Breastfed infants were the reference group.

OTHER

Feeding infants with standard formula milk

Infants enrolled were fed either with fermented formula milk or with standard formula during the first four months of life. Breastfed infants were the reference group.

OTHER

Breastfeeding infants

Reference group

Sponsors & Collaborators

  • Heinz Italia SpA

    collaborator INDUSTRY

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Fabio Mosca, Prof · NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-26
Primary Completion
2017-06-21
Completion
2017-06-21

Countries

  • Italy

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 NCT03637894 on ClinicalTrials.gov