Systemic Lupus ErythematosusNCT06641427
Different Aspects and Etiologies of Gastointestinal Bleeding in Patients With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
Trial summary
The association between SLE and development of of gastrointestinal bleeding Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Patient more than 18 years old classified as systemic lupus erythematosus Both sex
Who cannot join
- Patients with other clinical conditions that causes gastrointestinal bleeding as ulcerative colitis \& chrons
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The association between SLE and development of of gastrointestinal bleeding
Read the 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).
- Conditions
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
review diferrent aspects and causes of GIT bleeding in SLE patient
in this study we will review diferrent aspects and causes of GIT bleeding in SLE patient
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Noshy Baskales, Assiut University
- Investigators
- Zine alabden Ahmed Said, Principal investigator, Assiut UniversityEman Mohamed Ebrahem, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641427
- Sponsor's protocol ID
- GIT bleeding in SLE patients
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Aspects and Etiologies of Gastointestinal Bleeding in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06641427
- Acronym / sponsor ID
- GIT bleeding in SLE patients
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The association between SLE and development of of gastrointestinal bleeding
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patient more than 18 years old classified as systemic lupus erythematosus Both sex
Key exclusion criteria (1 listed)
- Patients with other clinical conditions that causes gastrointestinal bleeding as ulcerative colitis \& chrons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zine alabden Ahmed Said principal investigator
Assiut University
Eman Mohamed Ebrahem principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina Noshy Baskales (201126743927, mina.baskales@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
review diferrent aspects and causes of GIT bleeding in SLE patient (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.