NCT03637894

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
Last Updated

August 20, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

January 11, 2018

Last Update Submit

August 16, 2018

Conditions

Innate ImmunityNewbornsNutritionMicrobiota

Keywords

NewbornsFermented milkInnate immunity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Innate immunity at 30 days of life and at 90 days of life.

    Fecal dosage of catelecidines, alfa and beta defensins and sIgA

    0-7 days of life, at 30 days of life and at 90 days of life.

Secondary Outcomes (6)

  • Gastrointestinal tolerance

    0-7 days of life, at 30 days of life and at 90 days of life.

  • Weight

    0-7 days of life, at 30 days of life and at 90 days of life.

  • Body composition

    0-7 days of life and at 90 days of life.

  • Anthropometry

    0-7 days of life, at 30 days of life and at 90 days of life.

  • Microbiota

    0-7 days of life and at 90 days of life.

  • +1 more secondary outcomes

Study Arms (6)

Infants born by CS-fed fermented formula

ACTIVE COMPARATOR

Feeding infants with fermented formula milk. Infants born by cesarean section were fed either with fermented formula milk or with standard formula during the first 3 months of life

Dietary Supplement: Feeding infants with fermented formula milk

Infants born by CS-fed standard formula

PLACEBO COMPARATOR

Feeding infants with standard formula milk. Infants born by cesarean section were fed either with fermented formula milk or with standard formula during the first 3 months of life

Other: Feeding infants with standard formula milk

Infants born by CS-breastfed

OTHER

Infants born by cesarean section fed with mother milk during were the reference group for all infants born by cesarean section. The breastfeeding infants were the reference group

Other: Breastfeeding infants

Infants born by ED-fed fermented formula

ACTIVE COMPARATOR

Feeding infants with fermented formula milk. Infants born by eutocic delivery were fed either with fermented formula milk or with standard formula during the first 3 months of life

Dietary Supplement: Feeding infants with fermented formula milk

Infants born by ED-fed standard formula

PLACEBO COMPARATOR

Feeding infants with standard formula milk. Infants born by eutocic delivery were fed either with fermented formula milk or with standard formula during the first 3 months of life

Other: Feeding infants with standard formula milk

Infants born by ED-breastfed

OTHER

Infants born by eutocic delivery were fed either with fermented formula milk or with standard formula during the first 3 months of life. The breastfeeding infants were the reference group.

Other: Breastfeeding infants

Interventions

Feeding infants with fermented formula milkDIETARY_SUPPLEMENT

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.

Infants born by CS-fed fermented formulaInfants born by ED-fed fermented formula
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.

Infants born by CS-fed standard formulaInfants born by ED-fed standard formula
Breastfeeding infantsOTHER

Reference group

Infants born by CS-breastfedInfants born by ED-breastfed

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full term healthy infants
  • Gestational age from 37 to 41 weeks
  • Weight appropriate for gestational age (from 10th to 90th centile according to World Health Organization chart)
  • Human milk not available or not possible

You may not qualify if:

  • Weight small for gestational age (\< 10th centile) or large for gestational age (\> 90th centile) according to World Health Organization chart
  • Congenital abnormalities, chromosomal, hearth, gastrointestinal, respiratory, neurological or metabolic disease.
  • Perinatal infections
  • Positive familiarity for milk proteins allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (5)

  • Nocerino R, Paparo L, Terrin G, Pezzella V, Amoroso A, Cosenza L, Cecere G, De Marco G, Micillo M, Albano F, Nugnes R, Ferri P, Ciccarelli G, Giaccio G, Spadaro R, Maddalena Y, Berni Canani F, Berni Canani R. Cow's milk and rice fermented with Lactobacillus paracasei CBA L74 prevent infectious diseases in children: A randomized controlled trial. Clin Nutr. 2017 Feb;36(1):118-125. doi: 10.1016/j.clnu.2015.12.004. Epub 2015 Dec 17.

    PMID: 26732025RESULT

  • Zagato E, Mileti E, Massimiliano L, Fasano F, Budelli A, Penna G, Rescigno M. Lactobacillus paracasei CBA L74 metabolic products and fermented milk for infant formula have anti-inflammatory activity on dendritic cells in vitro and protective effects against colitis and an enteric pathogen in vivo. PLoS One. 2014 Feb 10;9(2):e87615. doi: 10.1371/journal.pone.0087615. eCollection 2014.

    PMID: 24520333RESULT

  • Thibault H, Aubert-Jacquin C, Goulet O. Effects of long-term consumption of a fermented infant formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on acute diarrhea in healthy infants. J Pediatr Gastroenterol Nutr. 2004 Aug;39(2):147-52. doi: 10.1097/00005176-200408000-00004.

    PMID: 15269618RESULT

  • Indrio F, Ladisa G, Mautone A, Montagna O. Effect of a fermented formula on thymus size and stool pH in healthy term infants. Pediatr Res. 2007 Jul;62(1):98-100. doi: 10.1203/pdr.0b013e31806772d3.

    PMID: 17515847RESULT

  • Roggero P, Liotto N, Pozzi C, Braga D, Troisi J, Menis C, Gianni ML, Berni Canani R, Paparo L, Nocerino R, Budelli A, Mosca F, Rescigno M. Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula. Nat Commun. 2020 Jun 1;11(1):2703. doi: 10.1038/s41467-020-16582-1.

    PMID: 32483147DERIVED

Study Officials

  • Fabio Mosca, Prof

    NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: RCT double blind study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

August 20, 2018

Study Start

August 26, 2015

Primary Completion

June 21, 2017

Study Completion

June 21, 2017

Last Updated

August 20, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

The individual participant data will not shared with other researchers.

Locations

IT(1)