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Supplementation of Infant Formula With Synbiotics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625273
First Posted: June 21, 2012
Last Update Posted: January 26, 2017
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.
Information provided by (Responsible Party):
Arla Foods
  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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01625273


Locations
Poland
Samodzielny Publiczny Dziecięcy Szpital Kliniczny
Warsaw, Poland, 01-184
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

Responsible Party: Arla Foods
ClinicalTrials.gov Identifier: NCT01625273     History of Changes
Other Study ID Numbers: KB/205/2010
First Submitted: June 19, 2012
First Posted: June 21, 2012
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:
F19
Lactobacillus paracasei paracasei