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

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00635388
First received: February 19, 2008
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Placebo
Other: Lactobacillus (Probiotic 1)
Other: Lactobacillus and Bifidobacterium (Probiotic 2)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Number of healthy days. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1 Other: Placebo
oral, placebo, once/day for 12 weeks
Experimental: 2 Other: Lactobacillus (Probiotic 1)
oral, Lactobacillus, once/day for 12 weeks
Experimental: 3 Other: Lactobacillus and Bifidobacterium (Probiotic 2)
oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks

  Eligibility

Ages Eligible for Study:   5 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635388

Locations
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Sponsors and Collaborators
Procter and Gamble
Investigators
Principal Investigator: Carl J Eastwood, MS Procter and Gamble
  More Information

No publications provided

Responsible Party: Carl J Eastwood, Procter & Gamble
ClinicalTrials.gov Identifier: NCT00635388     History of Changes
Other Study ID Numbers: 2007149
Study First Received: February 19, 2008
Last Updated: October 15, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013