SLENCT04517240
A Study on Protein Losing Enteropathy In Systemic Lupus Erythematosus
An observational study of SLE, run by Assiut University.
Trial summary
The aim of the current study is to investigate if there is GIT involvement in pt's with SLE particularly protein losing enteropathy also its prevalence among the studied cases and it's relation to disease activity . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SLE
- What is being tested?
- endoscopy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pt with systemic lupus with decreased protine in serum and don't have any other disease causing decrease protein
Who may be able to join
- all patients should fulfill ACR(1997)criteria for diagnosis of SLE newly diagnosed and not received immune suppressive regimens
Who cannot join
- Patients with acute gastroenteritis (fever, diarrhea and vomiting) . Patients with renal failure . Patients with heart failure. Patients with hepatic failure
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the current study is to investigate if there is GIT involvement in pt's with SLE particularly protein losing enteropathy also its prevalence among the studied cases and it's relation to disease activity .
Read the detailed description
Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body. Symptoms vary between people and may be mild to severe. Common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms Virtually every system and organ can be affected by SLE. Gastrointestinal symptoms are common in SLE patients, and more than half of them are caused by adverse reactions to medications and viral or bacterial infections. Though not as common as lupus nephritis, SLE-related gastrointestinal involvement is clinically important because most cases can be life-threatening if not treated promptly. Lupus mesenteric vasculitis is the most common cause, followed by protein-losing enteropathy, intestinal pseudo-obstruction, acute pancreatitis and other rare complications such as celiac disease, inflammatory bowel diseases, etc. Protein-losing gastroenteropathy (PLGE)is a condition characterized by profound edema and severe hypoalbuminemia secondary to excessive loss of serum protein from the gastrointestinal tract, clinically indistinguishable from nephrotic syndrome.
Gastrointestinal loss of albumin is harder to investigate, as is its etiology. Consequently, in patients with hypoalbuminemia in which other possible etiologies have been excluded, protein-losing enteropathy must be considered and persistently investigated. The diagnosis of lupus-associated protein-losing enteropathy relies on characteristic clinical and laboratory features of SLE and on the exclusion of other possible causes of protein loss. Usually there are no findings suggestive of lymphatic leakage, such as steatorrhea, lymphocytopenia, and hypogammaglobulinemia; complement levels were low and serum cholesterol was high in about 70% of the reported cases . No antibodies were specifically associated with protein-losing enteropathy.Colonoscopy in (PLGE)showed mucosal thickening in 44% of patients, and the majority of patients (52%) revealed no abnormalities; on the other hand, intestinal histology either revealed mucosal edema, inflammatory cell infiltrate, lymphangiectasia, mucosal atrophy or vasculitis in 80% of patients.Intestinal biopsy should be done to exclude other diseases but does not help in defining the etiopathogenesis of the protein loss. Intestinal biopsies were normal in many cases, and others showed nonspecific findings including mononuclear infiltration, lymphangiectasia, vasculitis, deposits of C3 in capillary walls, and shortened villi. Generally there are no lesions of the epithelial surface.calprotectin protein is found in large quantities in neutrophil granulocytes, where it represents 5% of total proteins and 60% of cytoplasmic proteins.In the presence of inflammatory processes, calprotectin is released following granulation of neutrophil granulocytes. In the case of an inflammation of the intestine, calprotectin can be detected in feces. Fecal dosing is the only one that can provide direct indications on the location of inflammation, while the dosage in serum or plasma shows a state of inflammation that can be present anywhere in the body of the analyzed patient.
- Conditions
- SLE
- Being tested
- endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyOther
Also called fecal calprotectin test
upper and lower endoscopy and fecal calprotectin test
What is being measured
The primary outcome is the main question the study is designed to answer.
early diagnosis of protein losing enteropathy in SLE
pt with sle have protein losing enteropathy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SLEStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DRRAMADAN, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517240
- Sponsor's protocol ID
- systemic lupus enteropathy
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perednia DA, Curosh NA. Lupus-associated protein-losing enteropathy. Arch Intern Med. 1990 Sep;150(9):1806-10.
PubMed 2203319
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Protein Losing Enteropathy In Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04517240
- Acronym / sponsor ID
- systemic lupus enteropathy
- Conditions
- SLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 Aug 2020 (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 aim of the current study is to investigate if there is GIT involvement in pt's with SLE particularly protein losing enteropathy also its prevalence among the studied cases and it's relation to disease activity .
Detailed description
Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body. Symptoms vary between people and may be mild to severe. Common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms Virtually every system and organ can be affected by SLE. Gastrointestinal symptoms are common in SLE patients, and more than half of them are caused by adverse reactions to medications and viral or bacterial infections. Though not as common as lupus nephritis, SLE-related gastrointestinal involvement is clinically important because most cases can be life-threatening if not treated promptly. Lupus mesenteric vasculitis is the most common cause, followed by protein-losing enteropathy, intestinal pseudo-obstruction, acute pancreatitis and other rare complications such as celiac disease, inflammatory bowel diseases, etc. Protein-losing gastroenteropathy (PLGE)is a condition characterized by profound edema and severe hypoalbuminemia secondary to excessive loss of serum protein from the gastrointestinal tract, clinically indistinguishable from nephrotic syndrome.
Gastrointestinal loss of albumin is harder to investigate, as is its etiology. Consequently, in patients with hypoalbuminemia in which other possible etiologies have been excluded, protein-losing enteropathy must be considered and persistently investigated. The diagnosis of lupus-associated protein-losing enteropathy relies on characteristic clinical and laboratory features of SLE and on the exclusion of other possible causes of protein loss. Usually there are no findings suggestive of lymphatic leakage, such as steatorrhea, lymphocytopenia, and hypogammaglobulinemia; complement levels were low and serum cholesterol was high in about 70% of the reported cases . No antibodies were specifically associated with protein-losing enteropathy.Colonoscopy in (PLGE)showed mucosal thickening in 44% of patients, and the majority of patients (52%) revealed no abnormalities; on the other hand, intestinal histology either revealed mucosal edema, inflammatory cell infiltrate, lymphangiectasia, mucosal atrophy or vasculitis in 80% of patients.Intestinal biopsy should be done to exclude other diseases but does not help in defining the etiopathogenesis of the protein loss. Intestinal biopsies were normal in many cases, and others showed nonspecific findings including mononuclear infiltration, lymphangiectasia, vasculitis, deposits of C3 in capillary walls, and shortened villi. Generally there are no lesions of the epithelial surface.calprotectin protein is found in large quantities in neutrophil granulocytes, where it represents 5% of total proteins and 60% of cytoplasmic proteins.In the presence of inflammatory processes, calprotectin is released following granulation of neutrophil granulocytes. In the case of an inflammation of the intestine, calprotectin can be detected in feces. Fecal dosing is the only one that can provide direct indications on the location of inflammation, while the dosage in serum or plasma shows a state of inflammation that can be present anywhere in the body of the analyzed patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pt with systemic lupus with decreased protine in serum and don't have any other disease causing decrease protein
Key inclusion criteria (1 listed)
- all patients should fulfill ACR(1997)criteria for diagnosis of SLE newly diagnosed and not received immune suppressive regimens
Key exclusion criteria (1 listed)
- Patients with acute gastroenteritis (fever, diarrhea and vomiting) . Patients with renal failure . Patients with heart failure. Patients with hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopyAlso: fecal calprotectin testupper and lower endoscopy and fecal calprotectin test | Other | – |
Primary outcome
early diagnosis of protein losing enteropathy in SLE
Time frame: baseline
pt with sle have protein losing enteropathy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Background: PubMed 2203319Perednia DA, Curosh NA. Lupus-associated protein-losing enteropathy. Arch Intern Med. 1990 Sep;150(9):1806-10.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, 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: status not confirmed, as of the sponsor's last update on 18 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact doaa ramadan (01007749061, doaa011180@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early diagnosis of protein losing enteropathy in SLE (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517240, which also lists 1 linked publication.
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 18 Aug 2020.