MedTrace Logo

Supplementation of Infant Formula With Synbiotics

NCT01625273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2017-01-26

No results posted yet for this study

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.

Conditions

  • Infant Formula

Interventions

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

Sponsors & Collaborators

  • Arla Foods

    lead INDUSTRY

Principal Investigators

  • Hania Szajewska, MD · Samodzielny Publiczny Dziecięcy Szpital, Warsaw

  • Jacek Witwicki, MD · Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01625273 on ClinicalTrials.gov