Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus

NCT07858461 — Not yet recruiting, 60 participants, Assiut University

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Evaluation of Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus at Assiut University Children Hospital

Registry	NCT07858461
Status	Not yet recruiting
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Systemic Lupus Erythematosus, Gastrointestinal Diseases
Dates	start 2026-09-30 (estimated), primary completion 2027-09-30 (estimated), completion 2028-02-20 (estimated), first posted 2026-10-05, last updated 2026-10-05

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Juvenile Systemic Lupus Erythematosus			Children with JSLE according to SLICC criteria with disease duration of at least 3 months.
Healthy Controls			Age- and sex-matched healthy children.

+Outcome measures

Primary outcomes

Mean fecal calprotectin level [Baseline]: Mean fecal calprotectin concentration measured by ELISA in µg/g.

Secondary outcomes

Proportion of children with elevated fecal calprotectin [Baseline]: Proportion of children with fecal calprotectin level above the laboratory reference range.
Proportion of children with abnormal intestinal ultrasound findings [Baseline]: Proportion of children showing bowel-wall thickening or increased vascularity on intestinal ultrasound.
Mean SLEDAI-2K score [Baseline]: Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Mean bowel wall thickness on ultrasound [Baseline]: Mean bowel wall thickness in millimeters measured by intestinal ultrasound.

+Eligibility

Sex: All, ages: 1 Year to 18 Years, accepts healthy volunteers

Inclusion Criteria:

* Children less than 18 years of age
* Diagnosis of juvenile systemic lupus erythematosus according to SLICC criteria
* Disease duration of at least 3 months
* Age- and sex-matched healthy controls
* Written informed consent from parents or legal guardians

Exclusion Criteria:

* \- Established diagnosis of inflammatory bowel disease or other primary gastrointestinal disorder
* Significant gastrointestinal manifestations (persistent abdominal pain, diarrhea, vomiting, GI bleeding, significant unexplained weight loss)
* Active gastrointestinal infection within the preceding 4 weeks
* Antibiotics, probiotics, or NSAIDs within the 2 weeks preceding stool sample collection
* Other autoinflammatory or overlapping autoimmune diseases
* Chronic liver or renal disease unrelated to JSLE

+Investigators

Mostafa s Khalaf, prof, Study chair, Pediatrics Department, Assiut University Hospitals