Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
NCT ID: NCT00724204
Last Updated: 2008-07-29
Study Results
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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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2006-04-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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A
Children that consumed a follow on formula without Lactobacillus salivarius CECT5713
follow on formula without probiotics
A follow on formula without probiotics
B
Children that consumed a follow on formula with Lactobacillus salivarius CECT5713
follow on formula with Lactobacillus salivarius CECT5713
follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day
Interventions
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follow on formula without probiotics
A follow on formula without probiotics
follow on formula with Lactobacillus salivarius CECT5713
follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cow's milk protein allergy
* Serious metabolic diseases
* Antibiotic treatment
* Serious gastrointestinal diseases
6 Months
6 Months
ALL
Yes
Sponsors
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Hospital Clinico Universitario San Cecilio
OTHER
Puleva Biotech
INDUSTRY
Responsible Party
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Puelav Biotech
Principal Investigators
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José A Maldonado, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics. Hospital Universitario San Cecilio
Mónica Olivares, PhD
Role: STUDY_CHAIR
Department of Nutrition and Health. Puleva Biotech. Granada
Federico Lara-Villoslada, PhD
Role: STUDY_DIRECTOR
Department of Nutrition and Helath. Puleva Biotech. Granada
Locations
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Hospital Universitario San Cecilio
Granada, Granada, Spain
Countries
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References
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Maldonado J, Lara-Villoslada F, Sierra S, Sempere L, Gomez M, Rodriguez JM, Boza J, Xaus J, Olivares M. Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children. Nutrition. 2010 Nov-Dec;26(11-12):1082-7. doi: 10.1016/j.nut.2009.08.023. Epub 2009 Dec 16.
Other Identifiers
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Safety Salivarius
Identifier Type: -
Identifier Source: org_study_id
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