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| ID | Type | Description | Link |
|---|---|---|---|
| 0120-131/2022/6 | Other Identifier | National Medical Ethics Committee of the Republic of Slovenia |
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The purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients. Based on collected data on protein kinetics, the study aims to further refine and personalize nutritional mixtures in patients with CIF. Additional aims include assessment of short-chain fatty acid metabolism and evaluation of gut microbiota function in patients with CIF.
This prospective cohort study evaluates anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure (CIF) receiving home parenteral nutrition. The study aims to improve therapy of CIF patients by providing new insights into metabolism and anabolic response. Protein kinetics will be assessed to better define protein requirements and to support optimization and personalization of parenteral nutrition mixtures. The study will also assess short-chain fatty acid metabolism and provide insight into gut microbiota function in CIF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Amino Acid Administration | Experimental | Patients with chronic intestinal failure receiving home parenteral nutrition receive intravenous amino acid administration for assessment of anabolic response and metabolic phenotype. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Amino Acids | Drug | Intravenous amino acid administration to assess anabolic response and protein kinetics in patients with chronic intestinal failure receiving home parenteral nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-Body Protein Kinetics (Protein Synthesis Rate) After Intravenous Amino Acid Infusion | Protein anabolic response will be assessed by whole-body protein kinetics using a stable isotope tracer methodology during intravenous amino acid administration. The outcome will be reported as the change in whole-body protein synthesis rate (µmol/kg/h) from baseline to post-infusion. | Baseline (prior to amino acid infusion) and immediately after amino acid infusion (within 1 day) |
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Inclusion Criteria:
- Patients with chronic intestinal failure (CIF) receiving home parenteral nutrition.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klavdija Korošec | Contact | +386 31630065 | kkorosec@onko-i.si | |
| Neža Gros | Contact | ngros@onko-i.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
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Single-group study assessing anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure receiving home parenteral nutrition.
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |