NCT05760729

Cognitive Impairment and Affective Mood Disorders in Patients With IBD

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-03-08
• Last updated: 2023-03-08

Locations

3 sites across 1 country: Romania