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Supplementation of Infant Formula With Synbiotics

This study is currently recruiting participants. (see Contacts and Locations)
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: July 4, 2014
Last verified: June 2012
  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:


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 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: IF (Infant formula)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 4, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Arla Foods:
F19
Lactobacillus paracasei paracasei

ClinicalTrials.gov processed this record on November 20, 2014