Different Aspects and Etiologies of Gastointestinal Bleeding in Patients With Systemic Lupus Erythematosus

NCT ID: NCT06641427

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The association between SLE and development of of gastrointestinal bleeding

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mina Noshy Baskales

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zine alabden Ahmed Said

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Eman Mohamed Ebrahem

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mina Noshy Baskales

Role: CONTACT

201126743927

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GIT bleeding in SLE patients

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.