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The aim is to evaluate the presence of mild cognitive impairment (MCI) in patients with inflammatory bowel disease (IBD). This will be done by cognitive tests. Along them, screening for depression, anxiety and stress will be done. A blood sample for determining serum values of homocysteine, protein S100-B, amyloid and BDNF will be stored. Patients will be followed-up for 2 years.
The aim is to evaluate the presence of mild cognitive impairment (MCI) in patients with inflammatory bowel disease (IBD). This will be done by cognitive tests. Along them, screening for depression, anxiety and stress will be done. A blood sample for determining serum values of homocysteine, protein S100-B, amyloid and BDNF will be stored. Patients will be followed-up for 2 years.
Study has 3 phases: inclusion, 1 year visit and 2 year visit. Inclusion: consent signing, checking exclusion and inclusion criteria, cognitive testing, blood sample storing, questionnaires for screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammatory bowel disease patients | It is mandatory to have a certain diagnosis of IBD before the inclusion. |
| |
| Healthy controls | Patients who have never had the diagnosis of inflammatory bowel disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive testing | Diagnostic Test | Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montreal cognitive assessment score (MOCA) | MOCA has 0-30 points | inclusion |
| Trail Making Test A (TMT-A) | Scored from 0-100 seconds | inclusion |
| Trail Making Test B (TMT-B) | Scored from 0-300 seconds | inclusion |
| Digit symbol substitution test | 0-90 points | inclusion |
| Forward digit span testing | 0-16 points | inclusion |
| Forward digit span testing | 0-16 points | 1 year |
| Forward digit span testing | 0-16 points | 2 years |
| Backward digit span testing | 0-14 points | inclusion |
| Backward digit span testing | 0-14 points | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Depression score | 0-42 points | inclusion |
| Quality of life score | 0-100 points for each domain 4 domains:
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients with certain diagnosis of IBD (history, histopathology, biopsy from endoscopy).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliviu Florențiu Sârb, MD | Contact | +40728027542 | sarboliviu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oliviu Florențiu Sârb | Recruiting | Cluj-Napoca | Cluj | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37824197 | Derived | Sarb OF, Vacaras V, Sarb A, Iacobescu M, Tantau AI. Cognitive Dysfunction and Affective Mood Disorder Screening in Patients With Chronic Inflammatory Bowel Disease: Protocol for a Prospective Case-Control Study. JMIR Res Protoc. 2023 Oct 12;12:e50546. doi: 10.2196/50546. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Blood serum samples, 5 ml from each patient
| Backward digit span testing |
0-14 points |
| 2 years |
| Serum homocysteine | mg/dl | inclusion |
| Serum brain derived neurotrophic factor (BDNF) | ug/ml | inclusion |
| Serum S100-B protein | ug/ml | inclusion |
| Serum amyloid | ug/ml | inclusion |
| Montreal cognitive assessment score (MOCA) | MOCA has 0-30 points | 1 year |
| Montreal cognitive assessment score (MOCA) | MOCA has 0-30 points | 2 years |
| inclusion |
| Stress score | 0-42 points | inclusion |
| Anxiety score | 0-42 points | inclusion |
| Clinica de Hepatologie si Gastroenterologie "Digenio" | Recruiting | Cluj-Napoca | Romania |
|
| Spitalul Clinic CF Cluj-Napoca | Recruiting | Cluj-Napoca | Romania |
|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |