Prevalence of Neuropsychiatric Manifestations in IBD Patients in Upper Egypt

October 1, 2020 updated by: Mohamed Roshdy Abdul-Sattar, Assiut University
Estimation of neuropsychiatric symptoms prevalence in IBD patients and their impact on quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of idiopathic inflammatory bowel disease (IBD), clearly distinct pathophysiological entities. UC, the most common form of IBD worldwide, is a disease of the colonic mucosa only; it is less prone to complications. In contrast, CD is a transmural disease of the gastrointestinal mucosa which can affect the entire gastrointestinal tract . CD and UC should be considered systemic diseases since they are associated with clinical manifestations involving organs outside the alimentary tract. Extraintestinal manifestations involve several organs, and either precede the onset of intestinal manifestations or appear and evolve in parallel with them . Neurologic involvement associated with IBD is frequently underreported. Nevertheless, it is important to quantify the morbidity burden of clinically significant neurologic complications in IBD because early recognition and treatment of neurologic diseases are crucial for preventing major morbidity . Neurologic involvement in IBD as a subgroup of the EIMs may precede the appearance of digestive symptoms or develop after diagnosis of IBD. In addition, neurological symptoms may exacerbate during flare-ups of IBD or evolve independently from intestinal manifestations without responding to treatment provided for the underlying bowel disease.Within (IBD) literature, anxiety and depression symptoms are commonly identified to be associated with increased disease activity and reduced quality of life. Research also indicates that ongoing psychological distress can exacerbate disease activity,] and increase the risk of flare-ups and health care costs. Given this, screening and targeted treatment of neuropsychological conditions in IBD patients are crucial.

Study Type

Observational

Enrollment (Anticipated)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients under the care of the hospital IBD outpatient service and having been diagnosed with IBD, aged over 18 years

Description

Inclusion Criteria:

  • patients under the care of the hospital IBD outpatient service and having been diagnosed with IBD, aged over 18 years, and able to complete the examination and questionnaire.

Exclusion Criteria:

  • Patients under the age of 18.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify prevalence of neurological and psychological conditions associated with IBD.
Time Frame: 2021-2022
2021-2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IBD and neuropsychiatry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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