Systemic Lupus ErythematosusNCT07858461
Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus and Gastrointestinal Diseases, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Gastrointestinal Diseases
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 20 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with juvenile systemic lupus erythematosus and age- and sex-matched healthy controls attending Assiut University Children Hospital.
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus at Assiut University Children Hospital
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.
Read the 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.
- Keywords
- Juvenile systemic, lupus erythematosus, Fecal calprotectin, Intestinal ultrasound, Subclinical gastrointestinal involvement, Assiut
- Medical subject headings
- Lupus Erythematosus, Systemic, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean fecal calprotectin level
Mean fecal calprotectin concentration measured by ELISA in µg/g.
Measured: Baseline
Secondary outcomes (4)
Proportion of children with elevated fecal calprotectin
Proportion of children with fecal calprotectin level above the laboratory reference range.
Measured: Baseline
Proportion of children with abnormal intestinal ultrasound findings
Proportion of children showing bowel-wall thickening or increased vascularity on intestinal ultrasound.
Measured: Baseline
Mean SLEDAI-2K score
Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Measured: Baseline
Mean bowel wall thickness on ultrasound
Mean bowel wall thickness in millimeters measured by intestinal ultrasound.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Kamal Mostafa Ahmed, Assiut University
- Investigators
- Mostafa s Khalaf, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858461
- Sponsor's protocol ID
- JSLE-GI-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07858461
- Acronym / sponsor ID
- JSLE-GI-Assiut-2026
- Keywords
- Juvenile systemic, lupus erythematosus, Fecal calprotectin, Intestinal ultrasound, Subclinical gastrointestinal involvement, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 5 Oct 2026 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with juvenile systemic lupus erythematosus and age- and sex-matched healthy controls attending Assiut University Children Hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean fecal calprotectin level
Time frame: Baseline
Mean fecal calprotectin concentration measured by ELISA in µg/g.
4 secondary outcomes
Proportion of children with elevated fecal calprotectin
Time frame: Baseline
Proportion of children with abnormal intestinal ultrasound findings
Time frame: Baseline
Mean SLEDAI-2K score
Time frame: Baseline
Mean bowel wall thickness on ultrasound
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- 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.
Mostafa s Khalaf, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Gastrointestinal Diseases, 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manar k M, Resident (+20 11 49443518, mnark024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean fecal calprotectin level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.