Different Aspects and Etiologies of Gastointestinal Bleeding in Patients With Systemic Lupus Erythematosus
October 12, 2024 updated by: Mina Noshy Baskales, Assiut University
The association between SLE and development of of gastrointestinal bleeding
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multisystem inflammation, variable clinical manifestations, and a variable clinical course.
It affects multiple systems and can occasionally manifest as hematological disorders and gastrointestinal (GI) tract abnormalities(1).
The complications of SLE are diverse and severe, and may include lupus pneumonitis, lupus encephalopathy, intestinal pseudo-obstruction, gastrointestinal bleeding, and vasculitis (2) .
The potential severity of SLE-related GI manifestations is concerning, considering that more than 50% of SLE patients develop GI symptoms at some point during the course of illness.
The incidence and prevalence of GI involvement during the course of SLE disease vary widely.
This could be due to less attention being paid to GI manifestations than other organ symptoms, such as lupus nephritis.
According to an autopsy study, 60-70% of SLE patients had evidence of peritonitis, whereas only 10% showed clinical manifestations throughout their lives(3).
Any part of the GI tract and the hepatobiliary system can be involved from the mouth to the anus.
The liver can also be affected by SLE; abnormal liver function test results were obtained in 23%-79% of cases and hepatomegaly in 39%-40%.
In terms of risk factors for GI involvement in SLE, SLE patients with Raynaud's phenomenon, hypocomplementemia, and positive anti-neutrophil cytoplasmic antibody were at increased risk of developing GI complications(4).
The main pathological mechanisms of GI involvement in SLE involved mesenteric vasculitis, intestinal pseudo-obstruction and protein losing enteropathy(5).
There is a wide variation of GI manifestations, including gastro-esophageal reflux, dysphagia, abdominal pain, constipation, diarrhea, faecal incontinence, intestinal pseudo-obstruction (IPO), perforations, and haemorrhage.
When GI presents as the initial affected system of SLE, there is likely to be a delay in the diagnosis(6).
Clinical presentations of GI lupus are non-specific and can be difficult to differentiate from infective, thrombotic, therapy-related and non-SLE aetiologies(7).
Study Type
Observational
Enrollment (Estimated)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mina Noshy Baskales
- Phone Number: 201126743927
- Email: mina.baskales@gmail.com
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
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patient more than 18 years old classified as systemic lupus erythematosus Both sex with no other clinical conditions that causes gastrointestinal bleeding as ulcerative colitis & chrons
Description
Inclusion Criteria:
- Patient more than 18 years old classified as systemic lupus erythematosus Both sex
Exclusion Criteria:
- Patients with other clinical conditions that causes gastrointestinal bleeding as ulcerative colitis & chrons
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 |
Measure Description |
Time Frame |
|---|---|---|
|
review diferrent aspects and causes of GIT bleeding in SLE patient
Time Frame: baseline
|
in this study we will review diferrent aspects and causes of GIT bleeding in SLE patient
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zine alabden Ahmed Said, Assiut University
- Principal Investigator: Eman Mohamed Ebrahem, Assiut University
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 (Estimated)
October 1, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
October 12, 2024
First Submitted That Met QC Criteria
October 12, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 12, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIT bleeding in SLE patients
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.