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

NCT ID: NCT01081067

Last Updated: 2011-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Stool Output

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Routine cow milk-based infant formula

No interventions assigned to this group

Investigational

Cow milk-based infant formula containing probiotics

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Mead Johnson Nutrition

Principal Investigators

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Hugo Ribeiro, Jr., M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor Edgard Santos University Hospital - UFBA

Locations

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Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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3377-1 (6008)

Identifier Type: -

Identifier Source: org_study_id

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