NCT01625273
Completed
Not Applicable
Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).
Arla Foods1 site in 1 country182 target enrollmentStarted: January 2010Last updated:
ConditionsInfant Formula
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Arla Foods
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Growth (body weight, length, head circumference)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 28 Days (Child)
- Sex
- 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
Outcomes
Primary Outcomes
Growth (body weight, length, head circumference)
Time Frame: From 28 days to 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Feeding Infant Formula With Added Probiotics and Whey Protein ConcentrateFocus on Healthy InfantsNCT01755481Arla Foods800
Completed
Not Applicable
Safety of Bifidobacterium Breve PS1 for InfantsInfant DevelopmentSafety IssuesNCT05973812Universidad Complutense de Madrid80
Completed
Not Applicable
Safety of Lactobacillus Fermentum in Newborn InfantsToleranceNCT01346644Puleva Biotech137
Completed
Not Applicable
Color Synbiotics StudyBeneficial Bacteria in GutNCT01813175Danone Asia Pacific Holdings Pte, Ltd.290
Active, not recruiting
Not Applicable
Infant Microbiota and Probiotic Intake StudyHealthyNCT02457338University of California, Davis120