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NCT Number: NCT06641427

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

The association between SLE and development of of gastrointestinal bleeding

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Key information

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mina Noshy Baskales

CONTACT

[email protected]

201126743927

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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