NCT00635388CompletedNot Applicable
A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3
Procter and Gamble1 site in 1 country360 target enrollmentStarted: February 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Number of healthy days.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
1
Sham Comparator
Intervention: Placebo (Other)
2
Experimental
Intervention: Lactobacillus (Probiotic 1) (Other)
3
Experimental
Intervention: Lactobacillus and Bifidobacterium (Probiotic 2) (Other)
Outcomes
Primary Outcomes
Number of healthy days.
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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