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

This study has been completed.

First Received: February 19, 2008 Last Updated: July 17, 2009 History of Changes

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00635388

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:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3

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
1: Sham Comparator	Other: Placebo oral, placebo, once/day for 12 weeks
2: Experimental	Other: Lactobacillus (Probiotic 1) oral, Lactobacillus, once/day for 12 weeks
3: Experimental	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:	Procter & Gamble ( Carl J Eastwood )
Study ID Numbers:	2007149
Study First Received:	February 19, 2008
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00635388 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Acidophilus
Healthy
Bifidobacterium

ClinicalTrials.gov processed this record on September 10, 2009