Supplementation of Infant Formula With Synbiotics

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01625273

Enrollment

182

Registered

2012-06-21

Start date

2010-01-31

Completion date

2016-04-30

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Formula

Keywords

F19, Lactobacillus paracasei paracasei

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.

Interventions

OTHERLactobacillus paracasei paracasei strain F19

Provided in an infant formula, 10\^8 CFU per day from 28 days to 6 months of infant age

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

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

Design outcomes

Primary

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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026