COGN-IBD-1: Cognitive Impairment and Affective Mood Disorders in Patients With IBD

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy (Other)

Overall Status

Recruiting

CT.gov ID

NCT05760729

Collaborator

(none)

Enrollment

Locations

43.9

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Mild Cognitive Impairment Depression Anxiety Stress Quality of Life	Diagnostic Test: Cognitive testing

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

May 30, 2025

Anticipated Study Completion Date :

May 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Inflammatory bowel disease patients It is mandatory to have a certain diagnosis of IBD before the inclusion.	Diagnostic Test: Cognitive testing 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	Diagnostic Test: Cognitive testing Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.

Arm

Intervention/Treatment

Inflammatory bowel disease patients

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

Diagnostic Test: Cognitive testing

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

Diagnostic Test: Cognitive testing

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

Outcome Measures

Primary Outcome Measures

Montreal cognitive assessment score (MOCA) [inclusion]
MOCA has 0-30 points
Trail Making Test A (TMT-A) [inclusion]
Scored from 0-100 seconds
Trail Making Test B (TMT-B) [inclusion]
Scored from 0-300 seconds
Digit symbol substitution test [inclusion]
0-90 points
Forward digit span testing [inclusion]
0-16 points
Forward digit span testing [1 year]
0-16 points
Forward digit span testing [2 years]
0-16 points
Backward digit span testing [inclusion]
0-14 points
Backward digit span testing [1 year]
0-14 points
Backward digit span testing [2 years]
0-14 points
Serum homocysteine [inclusion]
mg/dl
Serum brain derived neurotrophic factor (BDNF) [inclusion]
ug/ml
Serum S100-B protein [inclusion]
ug/ml
Serum amyloid [inclusion]
ug/ml
Montreal cognitive assessment score (MOCA) [1 year]
MOCA has 0-30 points
Montreal cognitive assessment score (MOCA) [2 years]
MOCA has 0-30 points

Secondary Outcome Measures

Depression score [inclusion]
0-42 points
Quality of life score [inclusion]
0-100 points for each domain 4 domains: Social relationships Environment Physical health Psychological
Stress score [inclusion]
0-42 points
Anxiety score [inclusion]
0-42 points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Oliviu Florențiu Sârb	Cluj-Napoca	Cluj	Romania
2	Clinica de Hepatologie si Gastroenterologie "Digenio"	Cluj-Napoca		Romania
3	Spitalul Clinic CF Cluj-Napoca	Cluj-Napoca		Romania