NCT01625273

Brief Summary

The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

6.2 years

First QC Date

June 19, 2012

Last Update Submit

January 25, 2017

Conditions

Infant Formula

Keywords

F19Lactobacillus paracasei paracasei

Outcome Measures

Primary Outcomes (1)

  • Growth (body weight, length, head circumference)

    From 28 days to 6 months

Study Arms (2)

IF (Infant formula)

NO INTERVENTION

IF with L. paracasei strain F19

EXPERIMENTAL
Other: Lactobacillus paracasei paracasei strain F19

Interventions

Lactobacillus paracasei paracasei strain F19OTHER

Provided in an infant formula, 10\^8 CFU per day from 28 days to 6 months of infant age

Also known as: F19
IF with L. paracasei strain F19

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy infants of mothers who voluntarily resigned completely from breastfeeding
  • infant age 28 days
  • delivered between 38 and 42 weeks of gestation
  • vaginal delivery
  • birth weight \> 2700 g and \< 4200 g
  • parent or the subject's legal representative has to speak and understand Polish

You may not qualify if:

  • fully or partially breastfed infants
  • malformations, handicaps or congenital diseases that could affect normal growth
  • treatment with antibiotics
  • fed infant formula with pre- and/or probiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samodzielny Publiczny Dziecięcy Szpital Kliniczny

Warsaw, 01-184, Poland

Location

Related Publications (1)

  • Sjodin KS, Sjodin A, Ruszczynski M, Kristensen MB, Hernell O, Szajewska H, West CE. Targeting the gut-lung axis by synbiotic feeding to infants in a randomized controlled trial. BMC Biol. 2023 Feb 20;21(1):38. doi: 10.1186/s12915-023-01531-3.

    PMID: 36803508DERIVED

MeSH Terms

Interventions

11-fluoro-19-nor-dihydro-testosterone

Study Officials

  • Hania Szajewska, MD

    Samodzielny Publiczny Dziecięcy Szpital, Warsaw

    PRINCIPAL INVESTIGATOR

  • Jacek Witwicki, MD

    Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

January 1, 2010

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)