Gut-brain Axis: Cognitive Dysfunction and Affective Mood Disorders in Patients With Chronic Inflammatory Bowel Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Enrollment
- 75
- Locations
- 3
- Primary Endpoint
- Trail Making Test B (TMT-B)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Oliviu Florentiu Sarb
Medical doctor
Iuliu Hatieganu University of Medicine and Pharmacy
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of IBD for IBD group.
- •No diagnosis of IBD for healthy controls group.
- •Obtainment of signed informed consent.
Exclusion Criteria
- •No consent form signed.
- •Severe organ insufficiency (cardiac, renal, respiratory, liver).
- •Prior severe head trauma.
- •Prior neurodegenerative disease.
- •Prior diagnosis of cognitive impairment or dementia.
- •Prior cardiac arrest.
- •Use of B9 and B12 vitamin supplements.
- •Involvement in other clinical trials.
- •Unclear diagnosis.
- •Prior psychiatric disorders.
Outcomes
Primary Outcomes
Trail Making Test B (TMT-B)
Time Frame: inclusion
Scored from 0-300 seconds
Serum S100-B protein
Time Frame: inclusion
ug/ml
Serum amyloid
Time Frame: inclusion
ug/ml
Digit symbol substitution test
Time Frame: inclusion
0-90 points
Montreal cognitive assessment score (MOCA)
Time Frame: 2 years
MOCA has 0-30 points
Trail Making Test A (TMT-A)
Time Frame: inclusion
Scored from 0-100 seconds
Forward digit span testing
Time Frame: 2 years
0-16 points
Backward digit span testing
Time Frame: 2 years
0-14 points
Serum homocysteine
Time Frame: inclusion
mg/dl
Serum brain derived neurotrophic factor (BDNF)
Time Frame: inclusion
ug/ml
Secondary Outcomes
- Depression score(inclusion)
- Anxiety score(inclusion)
- Stress score(inclusion)
- Quality of life score(inclusion)