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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Sham Comparator |
| |
| 2 | Experimental |
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| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | oral, placebo, once/day for 12 weeks |
| |
| Lactobacillus (Probiotic 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of healthy days. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl J Eastwood, MS | Procter and Gamble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cincinnati | Ohio | United States |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| Other |
oral, Lactobacillus, once/day for 12 weeks |
|
| Lactobacillus and Bifidobacterium (Probiotic 2) | Other | oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks |
|