Incidence of Infectious Diseases Clinical Trial
| Verified date | October 2010 |
| Source | Puleva Biotech |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Comité Ético de Investigación Clínica |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 188 |
| Est. completion date | |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Months to 7 Months |
| Eligibility |
Inclusion Criteria: - 6 months old children born at term - written consent from parents Exclusion Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Puleva Biotech |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of infectious diseases |