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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmentin/Probiotic | Experimental | Participants are provided in double blinded fashion probiotic to take with antibiotics |
|
| Augmentin/placebo | Experimental | Participants are provided in double blinded fashion placebo to take with antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic capsule once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg | Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The influence of probiotics on side effects associated with antibiotic use | Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects, | 3-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London/Ontario | Canada |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo |
| Dietary Supplement |
Placebo capsule once daily |
|
| D019602 |
| Food and Beverages |