NCT04256356

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 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Status
unknown

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

February 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 3, 2020

Last Update Submit

February 17, 2020

Conditions

Innate Immunity

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

    Time Frame: 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 (4)

Infants born by CS-fed fermented formula at double dosage

ACTIVE COMPARATOR

Infants born by CS-fed formula milk with fermented matrix at dosage of 4,6 g per 100g of powder (group fed with double dosage of fermented matrix compare trial FERCT15)

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

Infants born by CS-fed fermented formula at triple dosage

ACTIVE COMPARATOR

Infants born by CS-fed formula milk with fermented matrix at dosage of 6,9 g per 100g of powder (group fed with triple double dosage of fermented matrix compare trial FERCT15)

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

Infants born by CS-fed standard formula

PLACEBO COMPARATOR

Infants born by CS-fed formula milk without fermented matrix

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

Other: Breastfeeding infants

Interventions

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

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.

Infants born by CS-fed fermented formula at double dosage
Feeding infants with formula milk with fermented matrix at dosage of 6.9 g per 100g of powderDIETARY_SUPPLEMENT

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.

Infants born by CS-fed fermented formula at triple dosage
Feeding infants with standard formula milkOTHER

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.

Infants born by CS-fed standard formula
Breastfeeding infantsOTHER

reference group

Infants born by CS-breastfed

Eligibility Criteria

AgeUp to 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

Related Publications (4)

  • 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: 24520333BACKGROUND

  • 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: 15269618BACKGROUND

  • 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: 17515847BACKGROUND

  • 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

MeSH Terms

Interventions

Powders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Fabio Mosca, prof

    NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Mosca, prof

CONTACT

0255032907fabio.mosca@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

The individual participant data will not shared with other researchers.