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Supplementation of Infant Formula With Synbiotics

This study is currently recruiting participants.
Verified June 2012 by Arla Foods
Sponsor:
Information provided by (Responsible Party):
Arla Foods
ClinicalTrials.gov Identifier:
NCT01625273
First received: June 19, 2012
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Formula Feeding Infants
 Other: Lactobacillus paracasei paracasei strain F19

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arla Foods:

Primary Outcome Measures:
  • Growth (body weight, length, head circumference) [ Time Frame: From 28 days to 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: IF (Infant formula) Other: Lactobacillus paracasei paracasei strain F19
Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age
Other Name: F19
Experimental: IF with L. paracasei strain F19 Other: Lactobacillus paracasei paracasei strain F19
Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age
Other Name: F19

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625273

Contacts
Contact: Hania Szajewska, MD +48 22 452 3309 hania@ipgate.pl
Contact: Jacek Witwicki, MD +48 601 216 650 j.witwicki@bielanski.med.pl

Locations
Poland
Samodzielny Publiczny Dziecięcy Szpital Kliniczny Recruiting
Warsaw, Poland, 01-184
Contact: Hania Szajewska, MD     +48 22 452 3309     hania@ipgate.pl    
Principal Investigator: Hania Szajewska, MD            
Sponsors and Collaborators
Arla Foods
Investigators
Principal Investigator: Hania Szajewska, MD Samodzielny Publiczny Dziecięcy Szpital, Warsaw
Principal Investigator: Jacek Witwicki, MD Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw
  More Information

No publications provided

Responsible Party: Arla Foods
ClinicalTrials.gov Identifier: NCT01625273     History of Changes
Other Study ID Numbers: KB/205/2010
Study First Received: June 19, 2012
Last Updated: June 20, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Arla Foods:
F19
Lactobacillus paracasei paracasei

ClinicalTrials.gov processed this record on May 16, 2013