Trials / Completed
CompletedNCT00635388
A Study of the Effects of Probiotics in Children Grades 1-3
A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 360 (actual)
- Sponsor
- Procter and Gamble · Industry
- Sex
- All
- Age
- 5 Years – 9 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | oral, placebo, once/day for 12 weeks |
| OTHER | Lactobacillus (Probiotic 1) | oral, Lactobacillus, once/day for 12 weeks |
| OTHER | Lactobacillus and Bifidobacterium (Probiotic 2) | oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2008-03-13
- Last updated
- 2009-10-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00635388. Inclusion in this directory is not an endorsement.