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| Name | Class |
|---|---|
| Entrinsic Bioscience Inc. | INDUSTRY |
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Primary Objective:
To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control.
Secondary Objectives:
This prospective, phase 2 study is to assess how Enterade® will affect patient-reported quality of life and intestinal absorption in patients with Carcinoid Syndrome and Neuroendocrine Tumors. The hypothesis is that Enterade® when combined with standard supportive care will improve patient-reported quality of life and help maintain the small bowel's ability to absorb and retain fluids, possibly leading to a reduction in diarrhea frequency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NET with carcinoid syndrome | Active Comparator | Participants with NET and carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day. |
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| NET w/o cardinoid syndrome | Active Comparator | Participants with NET w/o carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acid Based Medical Food/Drink | Dietary Supplement | Study Compound Enterade® is a medical food drink/beverage composed of a proprietary blend of electrolytes and amino acids. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample. | ELISA assays will be used to assess pro-inflammatory cytokines IL-1β, IL-6 and TNFα and serum endotoxin from blood samples collected. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of increased bacterial translocation and systemic inflammation. | Gut inflammation will be assessed through the analysis of fecal lactoferrin using stool specimens. | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lowell Anthony | Lucille P. Markey Cancer Center at University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D003967 | Diarrhea |
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D009380 | Neoplasms, Nerve Tissue |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |