Status:
COMPLETED
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
Lead Sponsor:
Puleva Biotech
Conditions:
Incidence of Infectious Diseases
Eligibility:
All Genders
6-7 years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.
Eligibility Criteria
Inclusion
- 6 months old children born at term
- written consent from parents
Exclusion
- frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
- gastrointestinal surgery
- cow's milk protein allergy
- metabolic diseases (diabetes or lactose intolerance)
- immune deficiency
- antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT01215656
Start Date
May 1 2008
Last Update
October 7 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.