Supplementation of Infant Formula With Synbiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01625273
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):
Arla Foods

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.

Condition or disease Intervention/treatment Phase
Infant Formula Other: Lactobacillus paracasei paracasei strain F19 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
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).
Study Start Date : January 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Growth (body weight, length, head circumference) [ Time Frame: From 28 days to 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Arla Foods Identifier: NCT01625273     History of Changes
Other Study ID Numbers: KB/205/2010
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arla Foods:
Lactobacillus paracasei paracasei