A Study on Protein Losing Enteropathy In Systemic Lupus Erythematosus

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 .

Study Overview

• Status: Unknown
• Conditions: SLE
• Intervention / Treatment: Other: endoscopy

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

pt with systemic lupus with decreased protine in serum and don't have any other disease causing decrease protein

Description

Inclusion Criteria:

- all patients should fulfill ACR(1997)criteria for diagnosis of SLE newly diagnosed and not received immune suppressive regimens

Exclusion Criteria:

• Patients with acute gastroenteritis (fever, diarrhea and vomiting) . Patients with renal failure . Patients with heart failure. Patients with hepatic failure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early diagnosis of protein losing enteropathy in SLE	pt with sle have protein losing enteropathy	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Perednia DA, Curosh NA. Lupus-associated protein-losing enteropathy. Arch Intern Med. 1990 Sep;150(9):1806-10.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Autoimmune Diseases; Gastrointestinal Diseases; Connective Tissue Diseases; Intestinal Diseases; Lupus Erythematosus, Systemic; Protein-Losing Enteropathies
• Other Study ID Numbers: systemic lupus enteropathy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No