Supplementation of Infant Formula With Synbiotics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infant Formula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IF (Infant formula)

Group Type NO_INTERVENTION

No interventions assigned to this group

IF with L. paracasei strain F19

Group Type EXPERIMENTAL

Lactobacillus paracasei paracasei strain F19

Intervention Type OTHER

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

Interventions

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Lactobacillus paracasei paracasei strain F19

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

Intervention Type OTHER

Other Intervention Names

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F19

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes