Cognitive Impairment and Affective Mood Disorders in Patients With IBD

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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. year visit: cognitive testing. year visit: cognitive testing.

Official Title
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Gut-brain Axis: Cognitive Dysfunction and Affective Mood Disorders in Patients With Chronic Inflammatory Bowel Diseases

Conditions
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Inflammatory Bowel Diseases, Mild Cognitive Impairment, Depression, Anxiety, Stress, Quality of Life

Intervention / Treatment
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* Diagnostic Test: Cognitive testing


Participation Criteria
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Eligibility Criteria
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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. Pregnancy. Severe organ insufficiency (cardiac, renal, respiratory, liver). Prior severe head trauma. Neoplasia. 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. Prior use of neuroleptics. Proven history of familiar Alzheimer disease. Alcohol and drugs abuse. Prior stroke. Prior myocardial infarction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory bowel disease patients<br>It is mandatory to have a certain diagnosis of IBD before the inclusion. | Diagnostic Test: Cognitive testing<br>* Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.<br>|
| Healthy controls<br>Patients who have never had the diagnosis of inflammatory bowel disease | Diagnostic Test: Cognitive testing<br>* Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression score | 0-42 points | inclusion | 
| Quality of life score | 0-100 points for each domain 4 domains: Social relationships Environment Physical health Psychological | inclusion | 
| Stress score | 0-42 points | inclusion | 
| Anxiety score | 0-42 points | inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory bowel disease, mild cognitive impairment, depression, quality of life, mild cognitive impairment serum biomarkers