Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01081067

Enrollment

134

Registered

2010-03-05

Start date

2007-10-31

Completion date

2010-12-31

Last updated

2011-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stool Output

Brief summary

Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Detailed description

Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Months

Healthy volunteers

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

Countries

Brazil

Outcome results