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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Anna Pietrzak, MD contact

+48225690171

anpietrzak@gmail.com

Adam Kasprzyński, MD contact

660732225

adamkasprzynski@gmail.com

Poland1 site, 1 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

    Recruiting

Other trials in Poland

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.

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.

  1. 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)
  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.

  1. First posted29 Aug 2022
  2. Study start1 Oct 2022
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

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)
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

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.

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