Evaluating cognitive impairment and mood disorders in patients with inflammatory bowel disease

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

This study is trying to see if people with inflammatory bowel disease have mild cognitive issues and mood disorders like depression or anxiety by doing tests and collecting blood samples over two years.

Quick facts

• Study type: Observational
• Enrollment: 75 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy (Academic / other)
• Locations: 3 sites (Cluj-Napoca, Cluj and 2 other locations)
• Trial ID: NCT05760729 on ClinicalTrials.gov

What this trial studies

This study aims to assess the presence of mild cognitive impairment (MCI) in patients diagnosed with inflammatory bowel disease (IBD) through cognitive testing. Alongside cognitive assessments, participants will undergo screenings for depression, anxiety, and stress. Blood samples will be collected to analyze serum biomarkers associated with cognitive function. The study will follow participants over a two-year period with assessments at baseline, one year, and two years.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with inflammatory bowel disease who can provide informed consent.

Not a fit: Patients with severe organ insufficiency, prior neurodegenerative diseases, or significant psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cognitive and mood disorders in IBD patients, potentially leading to improved management strategies.

How similar studies have performed: While there is ongoing research into cognitive impairment in IBD, this specific approach focusing on serum biomarkers and mood disorders is relatively novel.

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.

Where this trial is running

Cluj-Napoca, Cluj and 2 other locations

• Oliviu Florențiu Sârb — Cluj-Napoca, Cluj, Romania (Recruiting)
• Clinica de Hepatologie si Gastroenterologie "Digenio" — Cluj-Napoca, Romania (Recruiting)
• Spitalul Clinic CF Cluj-Napoca — Cluj-Napoca, Romania (Recruiting)

Study contacts

• Study coordinator: Oliviu Florențiu Sârb, MD

Conditions Inflammatory Bowel Diseases; Mild Cognitive Impairment; Depression; Anxiety; Stress; Quality of Life; inflammatory bowel disease; mild cognitive impairment