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

Mead Johnson Nutrition

Status: Completed

Conditions: Stool Output

Study type: Observational

Funder types: Industry

Identifiers

NCT01081067

3377-1 (6008)

Details and patient eligibility

About

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

Full description

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

Enrollment: 134 estimated patients

Sex: All

Ages: 1 to 18 months old

Volunteers: No 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

Trial design

134 participants in 2 patient groups

Control

Description:

Routine cow milk-based infant formula

Investigational

Description:

Cow milk-based infant formula containing probiotics