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| Name | Class |
|---|---|
| Entera Health, Inc | INDUSTRY |
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This study will evaluate the use of a medical food, oral serum-derived bovine immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a wasting syndrome) improve their nutritional status and gain weight. The medical food is in powder form and is mixed with a liquid such as water or orange juice and consumed by swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the nutritional status of cachexic patients with advanced stages of COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inactive powder substance | Placebo Comparator | inactive powder substance by mouth twice a day for 6 months |
|
| serum bovine immunoglobulin (SBI) medical food | Experimental | SBI medical food 5 gr powder substance by mouth twice a day for 6 months |
|
| serum bovine immunoglobulin (SBI) medicalfood | Experimental | SBI medical food 10 gr powder substance by mouth twice a day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum bovine immunoglobulin (SBI) medical food | Dietary Supplement | Serum bovine immunoglobulin (SBI) is an FDA regulated, orally administered prescription medical food intended for the nutritional management of patients who are unable to absorb necessary nutrients as a result of therapeutic or chronic medical problems. |
| Measure | Description | Time Frame |
|---|---|---|
| The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The subtracted differences in swallowing-associated laryngeal Penetration Aspiration Scale (PAS) in patients receiving SBI or placebo at baseline and 6 months. | 6 months | |
| The subtracted differences in mean serum TNF-alpha and IL-6 concentrations between participants receiving SBI or placebo at baseline and 6 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Paoletti, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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|
| Placebo (for serum bovine immunoglobulin) | Dietary Supplement |
|
| 6 months |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |
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