Stool Output Clinical Trial
Official title:
Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
Evaluate the effect of probiotics on stool output in children 1 - 18 months old.
| Status | Completed |
| Enrollment | 134 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Month to 18 Months |
| Eligibility |
Inclusion Criteria: - children 1 - 18 months of age - acute diarrhea - adequately hydrated - signed informed consent Exclusion Criteria: - exclusively or predominantly breast-feeding - bloody diarrhea - intercurrent illnesses that may affect study parameters - use of systemic antibiotics during the 72 hours prior to enrollment - use of anti-diarrheal medications at the time of enrollment - use of supplement or infant formula with Lactobacillus rhamnosus 10 days prior to enrollment |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine | Salvador | Bahia |
| Lead Sponsor | Collaborator |
|---|---|
| Mead Johnson Nutrition |
Brazil,