Status:
COMPLETED
Fermented Milk and Fermented Rice on the Appearance of Respiratory and Gastrointestinal Symptoms
Lead Sponsor:
Federico II University
Conditions:
Gastrointestinal Infections
Respiratory Infections
Eligibility:
All Genders
12-48 years
Phase:
PHASE3
Brief Summary
The respiratory and gastrointestinal infections are a very common problem with high morbidity in children. These conditions were due, in general, immaturity and all "inexperience" of the immune system...
Eligibility Criteria
Inclusion
- children aged 12-48 months attending educational program (either at nursery or primary school)
Exclusion
- concomitant chronic/congenital diseases and disabilities,
- active tuberculosis,
- congenital cardiac defects,
- autoimmune diseases,
- immunodeficiency,
- chronic inflammatory bowel diseases,
- celiac diseases,
- cystic fibrosis,
- metabolic diseases,
- malignancy,
- chronic pulmonary diseases,
- malformation of the GI tract,
- history of allergy,
- severe wasting (less than 3 Standard deviations of weight-for-height z score),
- diarrhea on admission,
- antibiotic,
- pre/pro/symbiotic or immunostimulants use within 2 weeks before study start.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT01909128
Start Date
February 1 2013
End Date
June 1 2013
Last Update
March 19 2015
Active Locations (1)
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1
University of Naples Federico II
Naples, Italy, 80131