Inflammatory Bowel DiseasesCOGN-IBD-1NCT05760729
Cognitive Impairment and Affective Mood Disorders in Patients With IBD
An observational study of Inflammatory Bowel Diseases and Mild Cognitive Impairment, run by Iuliu Hatieganu University of Medicine and Pharmacy at 3 sites in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Mild Cognitive Impairment, Depression
- What is being tested?
- Cognitive testing
- How many people
- 75 participants
- Where
- 3 sitesRomania
- Study dates
- 1 Oct 2021to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with certain diagnosis of IBD (history, histopathology, biopsy from endoscopy).
Who may be able to join
- Diagnosis of IBD for IBD group.
- No diagnosis of IBD for healthy controls group.
- Obtainment of signed informed consent.
Who cannot join
- No consent form signed.
- Pregnancy.
- Severe organ insufficiency (cardiac, renal, respiratory, liver).
- Prior severe head trauma.
- Neoplasia.
- Prior neurodegenerative disease.
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Romania3 sites, 3 recruiting
- Recruiting
Oliviu Florențiu Sârb
Cluj-Napoca, Cluj
Oliviu Florențiu Sârb, 0728027542, sarboliviu@yahoo.com
Oliviu Florențiu Sarb, MD
- Recruiting
Clinica de Hepatologie si Gastroenterologie "Digenio"
Cluj-Napoca
Oliviu Florențiu Sârb, 0728027542, sarboliviu@yahoo.com
Oliviu Florențiu Sârb, MD
- Recruiting
Spitalul Clinic CF Cluj-Napoca
Cluj-Napoca
Oliviu Florențiu Sârb, 0728027542, sarboliviu@yahoo.com
Oliviu Florențiu Sârb, MD
About this study
Official title: Gut-brain Axis: Cognitive Dysfunction and Affective Mood Disorders in Patients With Chronic Inflammatory Bowel Diseases
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.
Read the 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.
- year visit: cognitive testing.
- year visit: cognitive testing.
- Conditions
- Inflammatory Bowel Diseases, Mild Cognitive Impairment, Depression, Anxiety, Stress, Quality of Life
- Being tested
- Cognitive testing
- Keywords
- inflammatory bowel disease, mild cognitive impairment, depression, quality of life, mild cognitive impairment serum biomarkers
- Medical subject headings
- Inflammatory Bowel Diseases, Cognitive Dysfunction, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive testingDiagnostic test
Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease patients | It is mandatory to have a certain diagnosis of IBD before the inclusion. Receives: Diagnostic Test: Cognitive testing | |
| Healthy controls | Patients who have never had the diagnosis of inflammatory bowel disease Receives: Diagnostic Test: Cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal cognitive assessment score (MOCA)
MOCA has 0-30 points
Measured: inclusion
Trail Making Test A (TMT-A)
Scored from 0-100 seconds
Measured: inclusion
Trail Making Test B (TMT-B)
Scored from 0-300 seconds
Measured: inclusion
Digit symbol substitution test
0-90 points
Measured: inclusion
Forward digit span testing
0-16 points
Measured: inclusion
Forward digit span testing
0-16 points
Measured: 1 year
Forward digit span testing
0-16 points
Measured: 2 years
Backward digit span testing
0-14 points
Measured: inclusion
Backward digit span testing
0-14 points
Measured: 1 year
Backward digit span testing
0-14 points
Measured: 2 years
Serum homocysteine
mg/dl
Measured: inclusion
Serum brain derived neurotrophic factor (BDNF)
ug/ml
Measured: inclusion
Serum S100-B protein
ug/ml
Measured: inclusion
Serum amyloid
ug/ml
Measured: inclusion
Montreal cognitive assessment score (MOCA)
MOCA has 0-30 points
Measured: 1 year
Montreal cognitive assessment score (MOCA)
MOCA has 0-30 points
Measured: 2 years
Secondary outcomes (4)
Depression score
0-42 points
Measured: inclusion
Quality of life score
0-100 points for each domain 4 domains:
- Social relationships
- Environment
- Physical health
- Psychological
Measured: inclusion
Stress score
0-42 points
Measured: inclusion
Anxiety score
0-42 points
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Oct 2021
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliviu Florentiu Sarb, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760729
- Sponsor's protocol ID
- 4687/01.10.2021
- Acronym
- COGN-IBD-1
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37824197
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut-brain Axis: Cognitive Dysfunction and Affective Mood Disorders in Patients With Chronic Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT05760729
- Acronym / sponsor ID
- COGN-IBD-1 / 4687/01.10.2021
- Conditions
- Inflammatory Bowel Diseases, Mild Cognitive Impairment, Depression, Anxiety, Stress, Quality of Life
- Keywords
- inflammatory bowel disease, mild cognitive impairment, depression, quality of life, mild cognitive impairment serum biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- year visit: cognitive testing.
- year visit: cognitive testing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease patients | – | Diagnostic Test: Cognitive testingIt is mandatory to have a certain diagnosis of IBD before the inclusion. |
| Healthy controls | – | Diagnostic Test: Cognitive testingPatients who have never had the diagnosis of inflammatory bowel disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with certain diagnosis of IBD (history, histopathology, biopsy from endoscopy).
Key inclusion criteria (3 listed)
- Diagnosis of IBD for IBD group.
- No diagnosis of IBD for healthy controls group.
- Obtainment of signed informed consent.
Key exclusion criteria (17 listed)
- No consent form signed.
- Pregnancy.
- Severe organ insufficiency (cardiac, renal, respiratory, liver).
- Prior severe head trauma.
- Neoplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive testingCognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing. | Diagnostic test | Healthy controls, Inflammatory bowel disease patients |
Primary outcome
Montreal cognitive assessment score (MOCA)
Time frame: inclusion
MOCA has 0-30 points
Trail Making Test A (TMT-A)
Time frame: inclusion
Scored from 0-100 seconds
Trail Making Test B (TMT-B)
Time frame: inclusion
Scored from 0-300 seconds
Digit symbol substitution test
Time frame: inclusion
0-90 points
Forward digit span testing
Time frame: inclusion
0-16 points
Forward digit span testing
Time frame: 1 year
0-16 points
Forward digit span testing
Time frame: 2 years
0-16 points
Backward digit span testing
Time frame: inclusion
0-14 points
Backward digit span testing
Time frame: 1 year
0-14 points
Backward digit span testing
Time frame: 2 years
0-14 points
Serum homocysteine
Time frame: inclusion
mg/dl
Serum brain derived neurotrophic factor (BDNF)
Time frame: inclusion
ug/ml
Serum S100-B protein
Time frame: inclusion
ug/ml
Serum amyloid
Time frame: inclusion
ug/ml
Montreal cognitive assessment score (MOCA)
Time frame: 1 year
MOCA has 0-30 points
Montreal cognitive assessment score (MOCA)
Time frame: 2 years
MOCA has 0-30 points
4 secondary outcomes
Depression score
Time frame: inclusion
Quality of life score
Time frame: inclusion
Stress score
Time frame: inclusion
Anxiety score
Time frame: inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 37824197Sarb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Mild Cognitive Impairment, run by Iuliu Hatieganu University of Medicine and Pharmacy at 3 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliviu Florențiu Sârb, MD (+40728027542, sarboliviu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal cognitive assessment score (MOCA) (time frame: inclusion). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.