Trials / Completed
CompletedNCT01346644
Safety of Lactobacillus Fermentum in Newborn Infants
Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 137 (actual)
- Sponsor
- Puleva Biotech · Industry
- Sex
- All
- Age
- 21 Days – 30 Days
- Healthy volunteers
- —
Summary
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Infant formula | Powder infant formula |
| OTHER | Infant formula | Powder infant formula |
Timeline
- Start date
- 2009-02-01
- First posted
- 2011-05-03
- Last updated
- 2013-05-16
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01346644. Inclusion in this directory is not an endorsement.