Supplementation of Infant Formula With Synbiotics

Arla Foods

Status: Completed

Conditions: Infant Formula

Treatments: Other: Lactobacillus paracasei paracasei strain F19

Study type: Interventional

Funder types: Industry

Identifiers

NCT01625273

KB/205/2010

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 2 patient groups

IF (Infant formula)

No Intervention group

IF with L. paracasei strain F19

Experimental group

Treatment:

Other: Lactobacillus paracasei paracasei strain F19