Supplementation of Infant Formula With Synbiotics

Infant Formula Clinical Trial

Official title:

Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625273
• Other study ID #: KB/205/2010
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: January 25, 2017
• Start date: January 2010
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Arla Foods
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infant Formula

Intervention

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

Locations

Country	Name	City	State
Poland	Samodzielny Publiczny Dzieciecy Szpital Kliniczny	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Arla Foods

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth (body weight, length, head circumference)		From 28 days to 6 months