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Due to a business decision to stop the project, the study was terminated early.
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| Name | Class |
|---|---|
| TyraTech Technology | UNKNOWN |
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The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Food Product | Placebo Comparator | Consumption of placebo food product |
|
| Novel Food Product | Experimental | Consumption of novel food product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Food Product | Other | Novel food product containing essential oil blend |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Safety and Tolerability using the Reactogenicity Questionairre | Reactogenicity will be assessed using a structured questionnaire on days 2, 14, 28, and 42 of the study. In addition, blood will be collected on study days 14 and 42 for assessment of basic hematologic and clinical chemistry parameters. | 43 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Diemert, MD, FRCP(C) | Rene Rachou Research Center, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisas Rene Rachou-FIOCRUZ | Minas Gerais | Brazil |
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| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| Control Food Product |
| Other |
Control food product |
|