Association between inflammatory bowel disease and other autoimmune disorders
| ISRCTN | ISRCTN78250941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78250941 |
- Submission date
- 30/11/2023
- Registration date
- 08/12/2023
- Last edited
- 18/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Inflammatory Bowel Disease (IBD) includes two types of chronic conditions, Ulcerative Colitis (UC) and Crohn's disease. IBD makes the intestines swollen and painful. The cause of IBD is not known, but it is believed that a person's immune system, genetic differences, and environmental factors may contribute to it.
This study aims to find out how common autoimmune disorders are in patients with IBD at a hospital in Riyadh, Saudi Arabia. The researchers will look at data from a specific point in time, to see how many patients have been diagnosed with both IBD and other autoimmune disorders. The study will help healthcare professionals better understand the prevalence of these disorders and how to treat them.
Who can participate?
This study is looking for adult patients who have been diagnosed with either Crohn's disease (CD) or ulcerative colitis (UC) based on internationally recognized standards.
What does the study involve? (for participants)
We will conduct a study in Riyadh, the capital city of Saudi Arabia, at a healthcare center that provides comprehensive care to patients with Inflammatory Bowel Disease (IBD). The center offers diagnosis, treatment, and follow-up services, and we will use medical records to gather data for our research. Our study will involve a focused and similar group of participants, allowing us to accurately assess our research objectives within the allotted time frame.
What are the possible benefits and risks of participating?
We're conducting a study in Saudi Arabia to determine the frequency of autoimmune disorders in IBD patients. This will help healthcare providers optimize care and treatment strategies for patients with IBD and autoimmune disorders. As a descriptive study, there is no risk involved.
Where is the study run from?
King Fahad Medical City (Saudi Arabia)
When is the study starting and how long is it expected to run for?
September 2023 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ahmed Alghamdi, agalghamdi@kfmc.med.sa
Contact information
Public, Scientific, Principal Investigator
Mohammed Bin Alqassim street
Riyadh
11322
Saudi Arabia
 ORCID ID |
0009-0004-5353-9357 |
|---|---|
| Phone | +966 112889999 EXT 21301 |
| aalghamedi80@gmail.com |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Prevalence of coexisting autoimmune disorders among inflammatory bowel disease (IBD) patients at a tertiary care centre in Riyadh, Saudi Arabia: a cross-sectional study |
| Study hypothesis | The study aims to assess the prevalence of coexisting autoimmune disorders among IBD patients |
| Ethics approval(s) |
Approved 12/09/2023, King Fahad Medical City (P.O. Box. 59046, Riyadh, 11525, Saudi Arabia; +966 11 288 9999 Ext: 15789; hsakkijha@kfmc.med.sa), ref: H-01-R-012 |
| Condition | Prevalence of coexisting autoimmune disorders among IBD patients |
| Intervention | The study will be conducted in Riyadh, the capital of Saudi Arabia, at a tertiary care center offering comprehensive care to many IBD patients, including diagnosis, treatment, and follow-up. Access to medical records within this setting will provide rich data sources. The study settings will ensure a focused and homogeneous group of participants, facilitating an accurate assessment of our research objectives within the given time frame |
| Intervention type | Not Specified |
| Primary outcome measure | Coexisting autoimmune disorders among (IBD) patients measured using patient records at a single time point |
| Secondary outcome measures | Disease severity and disease complication measured using patient records at a single time point |
| Overall study start date | 01/09/2023 |
| Overall study end date | 30/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 14 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | 1. Patients diagnosed with either CD or UC based on internationally recognized criteria. 2. Age 14 years or above. 3. IBD is currently being treated at a specialized medical facility. 4. Availability of complete medical records for data extraction. |
| Participant exclusion criteria | 1. Patients with an incomplete diagnosis of IBD. 2. Patients with a history of primary immunodeficiency disorders. 3. Patients who have received solid organ or bone marrow transplantation. |
| Recruitment start date | 13/09/2023 |
| Recruitment end date | 15/10/2023 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Riyadh
11525
Saudi Arabia
Sponsor information
Government
Khurias Road
Riyadh
11525
Saudi Arabia
| Phone | +966 11 288 9999 Ext: 15789 |
|---|---|
| hsakkijha@kfmc.med.sa | |
| Website | https://www.kfmc.med.sa/# |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The Journal of Research in Inflammatory Bowel Disease The Journal of Research in Gastroenterology and Hepatology |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. aalghamedi80@gmail.com |
Editorial Notes
18/01/2024: Internal review.
27/12/2023: Internal review.
08/12/2023: Trial's existence confirmed by King Fahad Medical City
