Cognitive Impairment and Affective Mood Disorders in Patients With IBD

Depression Clinical Trial

— COGN-IBD-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760729
• Other study ID #: 4687/01.10.2021
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: May 30, 2025

Study information

• Verified date: March 2023
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Oliviu Floren?iu Sârb, MD
• Phone: +40728027542
• Email: sarboliviu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Cognitive Dysfunction
• Depression
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Mild Cognitive Impairment
• Mood Disorders
• Quality of Life
• Stress

Intervention

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

Locations

Country	Name	City	State
Romania	Clinica de Hepatologie si Gastroenterologie "Digenio"	Cluj-Napoca
Romania	Oliviu Floren?iu Sârb	Cluj-Napoca	Cluj
Romania	Spitalul Clinic CF Cluj-Napoca	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal cognitive assessment score (MOCA)	MOCA has 0-30 points	inclusion
Primary	Trail Making Test A (TMT-A)	Scored from 0-100 seconds	inclusion
Primary	Trail Making Test B (TMT-B)	Scored from 0-300 seconds	inclusion
Primary	Digit symbol substitution test	0-90 points	inclusion
Primary	Forward digit span testing	0-16 points	inclusion
Primary	Forward digit span testing	0-16 points	1 year
Primary	Forward digit span testing	0-16 points	2 years
Primary	Backward digit span testing	0-14 points	inclusion
Primary	Backward digit span testing	0-14 points	1 year
Primary	Backward digit span testing	0-14 points	2 years
Primary	Serum homocysteine	mg/dl	inclusion
Primary	Serum brain derived neurotrophic factor (BDNF)	ug/ml	inclusion
Primary	Serum S100-B protein	ug/ml	inclusion
Primary	Serum amyloid	ug/ml	inclusion
Primary	Montreal cognitive assessment score (MOCA)	MOCA has 0-30 points	1 year
Primary	Montreal cognitive assessment score (MOCA)	MOCA has 0-30 points	2 years
Secondary	Depression score	0-42 points	inclusion
Secondary	Quality of life score	0-100 points for each domain 4 domains: Social relationships; Environment; Physical health; Psychological	inclusion
Secondary	Stress score	0-42 points	inclusion
Secondary	Anxiety score	0-42 points	inclusion