ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00635388
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : October 16, 2009
Sponsor:
Information provided by:
Procter and Gamble

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 children relative to a placebo control.

Condition or disease Intervention/treatment Phase
Healthy Other: Placebo Other: Lactobacillus (Probiotic 1) Other: Lactobacillus and Bifidobacterium (Probiotic 2) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3
Study Start Date : February 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of healthy days. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Carl J Eastwood, Procter & Gamble
ClinicalTrials.gov Identifier: NCT00635388     History of Changes
Other Study ID Numbers: 2007149
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009