Cognitive Impairment and Affective Mood Disorders in Patients With IBD
COGN-IBD-1
Gut-brain Axis: Cognitive Dysfunction and Affective Mood Disorders in Patients With Chronic Inflammatory Bowel Diseases
1 other identifier
observational
75
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedMarch 8, 2023
March 1, 2023
3.7 years
February 23, 2023
March 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
Montreal cognitive assessment score (MOCA)
MOCA has 0-30 points
inclusion
Trail Making Test A (TMT-A)
Scored from 0-100 seconds
inclusion
Trail Making Test B (TMT-B)
Scored from 0-300 seconds
inclusion
Digit symbol substitution test
0-90 points
inclusion
Forward digit span testing
0-16 points
inclusion
Forward digit span testing
0-16 points
1 year
Forward digit span testing
0-16 points
2 years
Backward digit span testing
0-14 points
inclusion
Backward digit span testing
0-14 points
1 year
Backward digit span testing
0-14 points
2 years
Serum homocysteine
mg/dl
inclusion
Serum brain derived neurotrophic factor (BDNF)
ug/ml
inclusion
Serum S100-B protein
ug/ml
inclusion
Serum amyloid
ug/ml
inclusion
Montreal cognitive assessment score (MOCA)
MOCA has 0-30 points
1 year
Montreal cognitive assessment score (MOCA)
MOCA has 0-30 points
2 years
Secondary Outcomes (4)
Depression score
inclusion
Quality of life score
inclusion
Stress score
inclusion
Anxiety score
inclusion
Study Arms (2)
Inflammatory bowel disease patients
It is mandatory to have a certain diagnosis of IBD before the inclusion.
Healthy controls
Patients who have never had the diagnosis of inflammatory bowel disease
Interventions
Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.
Eligibility Criteria
Patients with certain diagnosis of IBD (history, histopathology, biopsy from endoscopy).
You may qualify if:
- Diagnosis of IBD for IBD group.
- No diagnosis of IBD for healthy controls group.
- Obtainment of signed informed consent.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Oliviu Florențiu Sârb
Cluj-Napoca, Cluj, Romania
Clinica de Hepatologie si Gastroenterologie "Digenio"
Cluj-Napoca, Romania
Spitalul Clinic CF Cluj-Napoca
Cluj-Napoca, Romania
Related Publications (1)
Sarb OF, Vacaras V, Sarb A, Iacobescu M, Tantau AI. Cognitive Dysfunction and Affective Mood Disorder Screening in Patients With Chronic Inflammatory Bowel Disease: Protocol for a Prospective Case-Control Study. JMIR Res Protoc. 2023 Oct 12;12:e50546. doi: 10.2196/50546.
PMID: 37824197DERIVED
Biospecimen
Blood serum samples, 5 ml from each patient
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
February 23, 2023
First Posted
March 8, 2023
Study Start
October 1, 2021
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
March 8, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share