Anxiety, Depression, Inflammatory Bowel Diseases, Mild Cognitive Impairment, Quality of Life, Stress
Conditions
Keywords
inflammatory bowel disease, mild cognitive impairment, depression, quality of life, mild cognitive impairment serum biomarkers
Brief summary
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.
Detailed description
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. 1. year visit: cognitive testing. 2. year visit: cognitive testing.
Interventions
DIAGNOSTIC_TESTCognitive testing
Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of IBD for IBD group. 2. No diagnosis of IBD for healthy controls group. 3. Obtainment of signed informed consent.
Exclusion criteria
1. No consent form signed. 2. Pregnancy. 3. Severe organ insufficiency (cardiac, renal, respiratory, liver). 4. Prior severe head trauma. 5. Neoplasia. 6. Prior neurodegenerative disease. 7. Prior diagnosis of cognitive impairment or dementia. 8. Prior cardiac arrest. 9. Use of B9 and B12 vitamin supplements. 10. Involvement in other clinical trials. 11. Unclear diagnosis. 12. Prior psychiatric disorders. 13. Prior use of neuroleptics. 14. Proven history of familiar Alzheimer disease. 15. Alcohol and drugs abuse. 16. Prior stroke. 17. Prior myocardial infarction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum homocysteine | inclusion | mg/dl |
| Trail Making Test B (TMT-B) | inclusion | Scored from 0-300 seconds |
| Digit symbol substitution test | inclusion | 0-90 points |
| Forward digit span testing | inclusion | 0-16 points |
| Backward digit span testing | inclusion | 0-14 points |
| Serum brain derived neurotrophic factor (BDNF) | inclusion | ug/ml |
| Serum S100-B protein | inclusion | ug/ml |
| Serum amyloid | inclusion | ug/ml |
| Montreal cognitive assessment score (MOCA) | inclusion | MOCA has 0-30 points |
| Trail Making Test A (TMT-A) | inclusion | Scored from 0-100 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | inclusion | 0-100 points for each domain 4 domains: * Social relationships * Environment * Physical health * Psychological |
| Stress score | inclusion | 0-42 points |
| Anxiety score | inclusion | 0-42 points |
| Depression score | inclusion | 0-42 points |
Countries
Romania
Contacts
Primary ContactOliviu Florențiu Sârb, MD
Outcome results
None listed