Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
- 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
Trial population
Children with juvenile systemic lupus erythematosus and age- and sex-matched healthy controls attending Assiut University Children Hospital.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Juvenile Systemic Lupus Erythematosus
Group B: Healthy Controls
Trial outcomes
Primary outcomes
1
Mean fecal calprotectin level
Mean fecal calprotectin concentration measured by ELISA in µg/g.
Time frame
BaselineSecondary outcomes
1
Proportion of children with elevated fecal calprotectin
Proportion of children with fecal calprotectin level above the laboratory reference range.
Time frame
Baseline2
Proportion of children with abnormal intestinal ultrasound findings
Proportion of children showing bowel-wall thickening or increased vascularity on intestinal ultrasound.
Time frame
Baseline3
Mean SLEDAI-2K score
Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Time frame
Baseline4
Mean bowel wall thickness on ultrasound
Mean bowel wall thickness in millimeters measured by intestinal ultrasound.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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