Status:

COMPLETED

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

Lead Sponsor:

Procter and Gamble

Conditions:

Healthy

Eligibility:

All Genders

5-9 years

Phase:

NA

Brief 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 child...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

February 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2008

Estimated Enrollment :

360 Patients enrolled

Trial Details

Trial ID

NCT00635388

Start Date

February 1 2008

End Date

May 1 2008

Last Update

October 16 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Research Site

Cincinnati, Ohio, United States