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Supplementation of Infant Formula With Synbiotics

This study has been completed.
Information provided by (Responsible Party):
Arla Foods Identifier:
First received: June 19, 2012
Last updated: January 25, 2017
Last verified: January 2017
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
Infant Formula Other: Lactobacillus paracasei paracasei strain F19

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Enrollment: 182
Study Start Date: January 2010
Study Completion Date: April 2016
Primary Completion Date: March 2016 (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


Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01625273

Samodzielny Publiczny Dziecięcy Szpital Kliniczny
Warsaw, Poland, 01-184
Sponsors and Collaborators
Arla Foods
Principal Investigator: Hania Szajewska, MD Samodzielny Publiczny Dziecięcy Szpital, Warsaw
Principal Investigator: Jacek Witwicki, MD Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw
  More Information

Responsible Party: Arla Foods Identifier: NCT01625273     History of Changes
Other Study ID Numbers: KB/205/2010
Study First Received: June 19, 2012
Last Updated: January 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arla Foods:
Lactobacillus paracasei paracasei processed this record on September 18, 2017