A Study of the Effects of Probiotics in Children Grades 1-3
Not Applicable
Completed
- Conditions
- Healthy
- Registration Number
- NCT00635388
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of healthy days. 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Cincinnati, Ohio, United States
Research Site🇺🇸Cincinnati, Ohio, United States