Clinical trial NCT05760729: Cognitive Impairment and Affective Mood Disorders in Patients With IBD
Official title: Gut-brain Axis: Cognitive Dysfunction and Affective Mood Disorders in Patients With Chronic Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Mild Cognitive Impairment
Depression
Anxiety
Stress
Quality of Life
Keywords: inflammatory bowel disease
mild cognitive impairment
depression
quality of life
mild cognitive impairment serum biomarkers
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with certain diagnosis of IBD (history, histopathology, biopsy from endoscopy).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal cognitive assessment score (MOCA)
timeFrame: inclusion
measure: Trail Making Test A (TMT-A)
timeFrame: inclusion
measure: Trail Making Test B (TMT-B)
timeFrame: inclusion
measure: Digit symbol substitution test
timeFrame: inclusion
measure: Forward digit span testing
timeFrame: inclusion
measure: Forward digit span testing
timeFrame: 1 year
measure: Forward digit span testing
timeFrame: 2 years
measure: Backward digit span testing
timeFrame: inclusion
measure: Backward digit span testing
timeFrame: 1 year
measure: Backward digit span testing
timeFrame: 2 years
measure: Serum homocysteine
timeFrame: inclusion
measure: Serum brain derived neurotrophic factor (BDNF)
timeFrame: inclusion
measure: Serum S100-B protein
timeFrame: inclusion
measure: Serum amyloid
timeFrame: inclusion
measure: Montreal cognitive assessment score (MOCA)
timeFrame: 1 year
measure: Montreal cognitive assessment score (MOCA)
timeFrame: 2 years
Secondary outcomes:
measure: Depression score
timeFrame: inclusion
measure: Quality of life score
timeFrame: inclusion
measure: Stress score
timeFrame: inclusion
measure: Anxiety score
timeFrame: inclusion
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Oliviu Florențiu Sârb
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Clinica de Hepatologie si Gastroenterologie "Digenio"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic CF Cluj-Napoca
Study officials:
References: