Cognitive Impairment and Affective Mood Disorders in Patients With IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-05-30

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.

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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.

1. year visit: cognitive testing.
2. year visit: cognitive testing.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Inflammatory bowel disease patients

It is mandatory to have a certain diagnosis of IBD before the inclusion.

Cognitive testing

Intervention Type DIAGNOSTIC_TEST

Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.

Healthy controls

Patients who have never had the diagnosis of inflammatory bowel disease

Cognitive testing

Intervention Type DIAGNOSTIC_TEST

Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.

Interventions

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Cognitive testing

Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes