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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014