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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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