An observational study in Systemic Lupus Erythematosus and Gastrointestinal Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Assiut University · Observational
This cross-sectional case-control study aims to evaluate fecal calprotectin levels and intestinal ultrasound findings for the detection of subclinical gastrointestinal involvement in children with juvenile systemic lupus erythematosus compared with healthy controls.
Juvenile systemic lupus erythematosus is a chronic multisystem autoimmune disease. Gastrointestinal involvement may be under-recognized and can be subclinical.
This observational study will measure fecal calprotectin and perform intestinal ultrasound in children with JSLE and age- and sex-matched healthy controls to assess subclinical gastrointestinal involvement.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 60 is below the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with juvenile systemic lupus erythematosus and age- and sex-matched healthy controls attending Assiut University Children Hospital.
Exclusion Criteria:
Children with JSLE according to SLICC criteria with disease duration of at least 3 months.
Age- and sex-matched healthy children.
Mean fecal calprotectin level
Mean fecal calprotectin concentration measured by ELISA in µg/g.
Time frame: Baseline
Proportion of children with elevated fecal calprotectin
Proportion of children with fecal calprotectin level above the laboratory reference range.
Time frame: Baseline
Proportion of children with abnormal intestinal ultrasound findings
Proportion of children showing bowel-wall thickening or increased vascularity on intestinal ultrasound.
Time frame: Baseline
Mean SLEDAI-2K score
Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Time frame: Baseline
Mean bowel wall thickness on ultrasound
Mean bowel wall thickness in millimeters measured by intestinal ultrasound.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Assiut University