CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Feeding infants with fermented formula milk +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03637894
NCT03637894N/ACompleted

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

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·interventional·Posted Aug 20, 2018·Updated Aug 20, 2018

In Brief

A clinical study evaluating Feeding infants with fermented formula milk, Feeding infants with standard formula milk, and 1 other intervention for Innate Immunity and 3 related conditions. Completed, enrolled 96 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsHeinz Italia SpA

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 20, 2018
Enrollment StartAug 26, 2015
Primary CompletionJun 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.9 years ago

Interventions

Feeding infants with fermented formula milkdietary

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.

Feeding infants with standard formula milkother

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.

Breastfeeding infantsother

Reference group