Status:
COMPLETED
Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
Lead Sponsor:
Puleva Biotech
Collaborating Sponsors:
Hospital Clinico Universitario San Cecilio
Conditions:
Infection
Eligibility:
All Genders
6-6 years
Phase:
PHASE1
Brief Summary
The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six mo...
Eligibility Criteria
Inclusion
- Healthy six months old children
Exclusion
- Lactose intolerance
- Cow's milk protein allergy
- Serious metabolic diseases
- Antibiotic treatment
- Serious gastrointestinal diseases
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00724204
Start Date
April 1 2006
End Date
December 1 2007
Last Update
July 29 2008
Active Locations (1)
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1
Hospital Universitario San Cecilio
Granada, Granada, Spain, 18012