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| Name | Class |
|---|---|
| Evangelismos Hospital | OTHER |
| Sotiria General Hospital | OTHER |
| General Hospital of Nikaia "Saint Panteleimon" | OTHER |
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Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease and better health-related quality of life. The prevalence of malnutrition in patients with Crohn's disease varies and is higher in patients with active disease. Available studies in the literature have assessed the nutritional status of patients with Crohn's disease. However, sample size of available studies is small and highly heterogeneous, and most patients are hospitalized with active disease. The aim of the present study is a thorough assessment of nutritional status of 250 patients either with active Crohn's disease or in remission of the disease using multiple widely available tools and methods, in order to assess their accuracy and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition, sarcopenia, sarcopenic obesity and cachexia as well as overweight and obesity. Finally, the effect of the nutritional status on the course of the disease will be investigated.
The study sample will comprise of 250 adults with proven Crohn's disease, either with active disease or in remission phase. A detailed medical and nutritional assessment will be implemented at baseline. Data regarding the hospitalizations, disease relapse, duration of remission and complications of all the patients will be collected one year after the baseline assessment.
More specifically regarding the detailed assessment, firstly, gastroenterologists of the research team will complete a full medical record regarding the localization of the disease, activity of disease (active or remission), complications, comorbidities and medication. The activity of Crohn's disease will be assessed using the Harvey-Bradshaw Index (HBI). Blood will be collected for all patients with Crohn's Disease.
Furthermore, in the Laboratory of Clinical Nutrition & Dietetics at Harokopio University, patients will participate in the following procedures:
In addition, patients' nutritional risk or nutritional status will be assessed through several previously validated tools like the Subjective Global Assessment, the Nutrition Risk Score 2002, the Malnutrition Universal Screening Tool, the efficacy of which will be tested in the present study. Patients will be also categorized according to GLIM criteria for the diagnosis of malnutrition.
Six months and twelve months after the baseline assessment of the study samples, data will be collected regarding the hospitalizations, disease relapse, duration of remission and complications of all the patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of malnutrition phenotypes | Prevalence of different malnutrition phenotypes (e.g. undernutrition, sarcopenia, sarcopenic obesity), in crohn disease patients either with active disease or in remission, by implementing a thorough nutritional assessment. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Validity test of available tools | Test the sensitivity, specificity, positive and negative prognostic values of already available tools for nutritional screening or assessment against a combined index as the reference tool. If no tool is estimated as valid, a new combination of nutritional, biochemical and/or clinical parameters will be synthesized and its validity as a new screening or assessment tool will be assessed for the detection of cirrhotic patients at risk of malnutrition or already malnourished. |
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Inclusion Criteria:
Exclusion Criteria:
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250 adult patients with active Crohn's Disease or in remission phase
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harokopio University | Athens | Kallithea | 17671 | Greece |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D044342 | Malnutrition |
| D050177 | Overweight |
| D009765 | Obesity |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Baseline |
| D007410 | Intestinal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |