Supplementation of Infant Formula With Synbiotics

January 25, 2017 updated by: Arla Foods

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-184
        • Samodzielny Publiczny Dzieciecy Szpital Kliniczny

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: IF (Infant formula)
EXPERIMENTAL: IF with L. paracasei strain F19
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
Other Names:
  • F19

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arla Foods

Investigators

  • Principal Investigator: Hania Szajewska, MD, Samodzielny Publiczny Dziecięcy Szpital, Warsaw
  • Principal Investigator: Jacek Witwicki, MD, Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (ESTIMATE)

June 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KB/205/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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