Inflammatory Bowel DiseasesPEIBDNCT05519904
Prevalence of Encephalopathy in Patients With Inflammatory Bowel Diseases
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis Chronic, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are characterized by extraintestinal manifestations in approximately 30% of cases. Only 3% of these manifestations are neurological diseases, but they have serious consequences for the patient's health, and often constitute a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis Chronic, Crohn Disease
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2022to 31 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory bowel diseases who within 12 months were: * hospitalized at the Department of Gastroenterology in Bielanski Hospital in Warsaw, * patients consulted at the Gastroenterology Outpatient Clinic * patients reporting for outpatient endoscopic examinations at the Endoscopy Unit Among these people, a group of patients treated with biological or biomimetic drugs will be distinguished, due to the correlation, as indicated in the literature, between the use of anti-TNF drugs and the occurrence of disturbances in the functioning of the nervous system.
Who may be able to join
- Patients with Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
Who cannot join
- The study group will exclude people who do not respond to pharmacological treatment, including biological / biomimetic drugs, and will be referred for surgery, as well as people with previously diagnosed neuropsychiatric diseases. In addition, the study will exclude patients with nervous system diseases and liver diseases who are suspected or diagnosed with encephalopathy.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Szpital Bielański im. Jerzego Popiełuszki
Warsaw, Masovian Voivodeship, 01-809
Anna Pietrzak, MD, +48225690171, anpietrzak@gmail.com
Adam Kasprzyński, MD, +48660732225, adamkasprzynski@gmail.com
About this study
Official title: Prevalence of Encephalopathy in Patients With Inflammatory Bowel Diseases.
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are characterized by extraintestinal manifestations in approximately 30% of cases. Only 3% of these manifestations are neurological diseases, but they have serious consequences for the patient's health, and often constitute a significant diagnostic problem. Neurological symptoms may precede the appearance of IBD symptoms by up to several years. According to the available literature, symptoms of neurological diseases are more common in men and are usually diagnosed after the diagnosis of IBD, but they are rarely associated with exacerbations of the disease. The most common of these are demyelinating diseases such as multiple sclerosis. The very application of treatment in patients with IBD may also play an important role in the development of neurological diseases of various types and pathogenesis. The use of immunosuppressants and therapy with biological drugs may lead to the impairment of the central nervous system due to changes in the white matter of the brain, a predisposition to opportunistic infections, John Cunningham virus infections and the resulting progressive multifocal leukoencephalopathy (PML). So far, the literature describes the occurrence of many neurological diseases in patients with coexisting IBD, caused by side effects of the treatment itself, cerebral vascular diseases or caused by immune disorders. Cases of Wernicke encephalopathy caused by vitamin B1 deficiency have also been reported. A broad term that defines symptoms of not only neurological diseases is encephalopathy. By definition, it means damage or disease that affects the brain. It occurs when the way the brain works is changed due to a change in the body. These changes cause changes in the psyche, causing confusion and a change in typical behavior. Encephalopathy is not a single disease entity but a disorder with complex pathophysiology. It is a serious disease that, if untreated (or rather its underlying cause), leads to permanent brain damage. Due to the variety of symptoms and their variable severity, the diagnosis of encephalopathy often escapes the team of chronically ill patients. Patients with IBD are such a group - young patients whose severe, incurable disease changes their philosophy of life. The influence of IBD on encephalopathy symptoms has not been evaluated so far. This study is designed to answer the question of whether encephalopathy occurs in people with IBD. By extrapolating the incidence of encephalopathy in people with another immunologically mediated disease, Hashimoto's disease, we hypothesized that such a disorder could also occur in people with IBD. We assume that autoimmune mechanisms underlying the disease will contribute to the etiopathogenesis of the phenomenon, similarly to thyroid disease. Additionally, with increasing incidence in the scientific literature, it is stated that in about 30% of cases, IBD symptoms overlap with functional bowel diseases such as Irritable Bowel Syndrome (IBS), so we plan, in the questionnaire presented to patients, to include questions regarding the coexistence of these disorder as described in the Roman IV Criteria.
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis Chronic, Crohn Disease, Irritable Bowel Syndrome, Encephalopathy
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Irritable Bowel Syndrome, Brain Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of encephalopathy in patients with Inflammatory Bowel Disease
Finding the presence or absence of symptoms of encephalopathy in people with IBD
Measured: 2-3 Months
Secondary outcomes (1)
Number of patients with overlapping symptoms of Inflammatory Bowel Diseases and Irritable Bowel Syndrome
In addition, due to the fact that in about 30% of cases, the overlap of IBD symptoms with functional bowel diseases, such as Irritable Bowel Syndrome (IBS), we are planning presented to patients, include questions regarding the coexistence of these disorders described in the Roman IV Criteria.
Measured: 2-3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Oct 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Pietrzak, MD, Principal investigator, Medical Centre of Postgraduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519904
- Sponsor's protocol ID
- nr 59/2022
- Acronym
- PEIBD
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Encephalopathy in Patients With Inflammatory Bowel Diseases.
- ClinicalTrials.gov ID
- NCT05519904
- Acronym / sponsor ID
- PEIBD / nr 59/2022
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis Chronic, Crohn Disease, Irritable Bowel Syndrome, Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 29 Aug 2022 (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.
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are characterized by extraintestinal manifestations in approximately 30% of cases. Only 3% of these manifestations are neurological diseases, but they have serious consequences for the patient's health, and often constitute a significant diagnostic problem. Neurological symptoms may precede the appearance of IBD symptoms by up to several years. According to the available literature, symptoms of neurological diseases are more common in men and are usually diagnosed after the diagnosis of IBD, but they are rarely associated with exacerbations of the disease. The most common of these are demyelinating diseases such as multiple sclerosis. The very application of treatment in patients with IBD may also play an important role in the development of neurological diseases of various types and pathogenesis. The use of immunosuppressants and therapy with biological drugs may lead to the impairment of the central nervous system due to changes in the white matter of the brain, a predisposition to opportunistic infections, John Cunningham virus infections and the resulting progressive multifocal leukoencephalopathy (PML). So far, the literature describes the occurrence of many neurological diseases in patients with coexisting IBD, caused by side effects of the treatment itself, cerebral vascular diseases or caused by immune disorders. Cases of Wernicke encephalopathy caused by vitamin B1 deficiency have also been reported. A broad term that defines symptoms of not only neurological diseases is encephalopathy. By definition, it means damage or disease that affects the brain. It occurs when the way the brain works is changed due to a change in the body. These changes cause changes in the psyche, causing confusion and a change in typical behavior. Encephalopathy is not a single disease entity but a disorder with complex pathophysiology. It is a serious disease that, if untreated (or rather its underlying cause), leads to permanent brain damage. Due to the variety of symptoms and their variable severity, the diagnosis of encephalopathy often escapes the team of chronically ill patients. Patients with IBD are such a group - young patients whose severe, incurable disease changes their philosophy of life. The influence of IBD on encephalopathy symptoms has not been evaluated so far. This study is designed to answer the question of whether encephalopathy occurs in people with IBD. By extrapolating the incidence of encephalopathy in people with another immunologically mediated disease, Hashimoto's disease, we hypothesized that such a disorder could also occur in people with IBD. We assume that autoimmune mechanisms underlying the disease will contribute to the etiopathogenesis of the phenomenon, similarly to thyroid disease. Additionally, with increasing incidence in the scientific literature, it is stated that in about 30% of cases, IBD symptoms overlap with functional bowel diseases such as Irritable Bowel Syndrome (IBS), so we plan, in the questionnaire presented to patients, to include questions regarding the coexistence of these disorder as described in the Roman IV Criteria.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory bowel diseases who within 12 months were: * hospitalized at the Department of Gastroenterology in Bielanski Hospital in Warsaw, * patients consulted at the Gastroenterology Outpatient Clinic * patients reporting for outpatient endoscopic examinations at the Endoscopy Unit Among these people, a group of patients treated with biological or biomimetic drugs will be distinguished, due to the correlation, as indicated in the literature, between the use of anti-TNF drugs and the occurrence of disturbances in the functioning of the nervous system.
Key inclusion criteria (1 listed)
- Patients with Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
Key exclusion criteria (1 listed)
- The study group will exclude people who do not respond to pharmacological treatment, including biological / biomimetic drugs, and will be referred for surgery, as well as people with previously diagnosed neuropsychiatric diseases. In addition, the study will exclude patients with nervous system diseases and liver diseases who are suspected or diagnosed with encephalopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of encephalopathy in patients with Inflammatory Bowel Disease
Time frame: 2-3 Months
Finding the presence or absence of symptoms of encephalopathy in people with IBD
1 secondary outcome
Number of patients with overlapping symptoms of Inflammatory Bowel Diseases and Irritable Bowel Syndrome
Time frame: 2-3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Anna Pietrzak, MD principal investigator
Medical Centre of Postgraduate Education
1 site 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 Ulcerative Colitis Chronic, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 1 inclusion and 1 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 Anna Pietrzak, MD (+48225690171, anpietrzak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of encephalopathy in patients with Inflammatory Bowel Disease (time frame: 2-3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.