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| ID | Type | Description | Link |
|---|---|---|---|
| 07-112 |
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| Name | Class |
|---|---|
| Jarrow Formulas Inc | INDUSTRY |
| Institut Rosell | OTHER |
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The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving antibiotic therapy.
A common complication of antibiotic use is antibiotic-induced diarrhea (AAD). AAD is the result of disrupted microflora, occurring two to eight weeks after antibiotic use. Probiotic supplementation may rebalance the intestinal flora, thus reducing the incidence of diarrhea, improving quality of life and reducing symptoms associated with antibiotic administration.
The proposed study will be a prospective, randomized, double blind, placebo-controlled trial that will assess the efficacy of the Jarro-Dophilus EPS probiotics formula for the prevention of AAD.
In addition,a subgroup of participants will be requested to provide one fecal sample at the initiation of the study and one sample in the last three days of probiotic (or placebo) treatment. The samples will undergo microbial analysis for routine C & S(Salmonella, Shigella, Campylobacter, Ecoli 0157, Yersinia), VRE, Yeast, Fungus culture (moulds) and C. difficile toxin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Jarrow-Dophilus EPS |
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| 2 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jarro-Dophilus EPS probiotics | Other | Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of patients experiencing diarrhea | Duration of antibiotic course plus 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of diarrhea | Duration of antibiotic course plus 3 weeks | |
| Quality of life. | Duration of antibiotic course plus 3 weeks | |
| Gastrointestinal Symptom Rating Scale score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne M Shevchuk, B.S.P., Pharm D. | College of Pharmacy and Nutrition, University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saskatchewan | Saskatoon | Saskatchewan | S7N 5C9 | Canada |
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| Duration of antibiotic course plus 3 weeks |
| Incidence of adverse effects. | Duration of antibiotic course plus 3 weeks |
| Presence of pathogens in fecal samples. | Duration of antibiotic course |