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

NCT00635388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2009-10-16

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

OTHER

Placebo

oral, placebo, once/day for 12 weeks

OTHER

Lactobacillus (Probiotic 1)

oral, Lactobacillus, once/day for 12 weeks

OTHER

Lactobacillus and Bifidobacterium (Probiotic 2)

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

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Carl J Eastwood, MS · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635388 on ClinicalTrials.gov