Infant Formula Clinical Trial
Official title:
Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).
Verified date | January 2017 |
Source | Arla Foods |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 182 |
Est. completion date | April 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 28 Days |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Samodzielny Publiczny Dzieciecy Szpital Kliniczny | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Arla Foods |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Growth (body weight, length, head circumference) | From 28 days to 6 months |
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