Supplementation of Infant Formula With Synbiotics

Not Applicable

Completed

• Conditions: Infant Formula

• Registration Number: NCT01625273
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Growth (body weight, length, head circumference)	From 28 days to 6 months

Trial Locations

Locations (1)

Samodzielny Publiczny Dziecięcy Szpital Kliniczny; 🇵🇱 Warsaw, Poland