A Study of the Effects of Probiotics in Children Grades 1-3

NCT ID: NCT00635388

Last Updated: 2009-10-16

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

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

Brief Summary

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The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type SHAM_COMPARATOR

Placebo

Intervention Type OTHER

oral, placebo, once/day for 12 weeks

2

Group Type EXPERIMENTAL

Lactobacillus (Probiotic 1)

Intervention Type OTHER

oral, Lactobacillus, once/day for 12 weeks

3

Group Type EXPERIMENTAL

Lactobacillus and Bifidobacterium (Probiotic 2)

Intervention Type OTHER

oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks

Interventions

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Placebo

oral, placebo, once/day for 12 weeks

Intervention Type OTHER

Lactobacillus (Probiotic 1)

oral, Lactobacillus, once/day for 12 weeks

Intervention Type OTHER

Lactobacillus and Bifidobacterium (Probiotic 2)

oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be in good general health as reported by their parent(s)/legal guardian;
* Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
* Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)

Exclusion Criteria

* Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Procter & Gamble

Principal Investigators

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Carl J Eastwood, MS

Role: PRINCIPAL_INVESTIGATOR

Procter and Gamble

Locations

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Research Site

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2007149

Identifier Type: -

Identifier Source: org_study_id

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