Caspase-1 Activity, IL-1beta, and IL-18 in Patients With FMF
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorHitit University
About this trial
This study aims to investigate the intestinal mucosal expression of key inflammatory markers, namely Interleukin-1 (IL-1), Interleukin-18 (IL-18), and Caspase-1, in patients with Familial Mediterranean Fever (FMF). FMF is an autoinflammatory disorder characterized by recurrent episodes of fever and serosal inflammation. Recent studies suggest a possible role of intestinal immune activation in the disease pathogenesis, particularly through inflammasome-related cytokines. To better understand mucosal involvement in FMF, immunohistochemical staining for IL-1, IL-18, and Caspase-1 will be performed on intestinal biopsy samples obtained during routine endoscopic procedures. The staining intensity and distribution patterns will be evaluated and compared with age- and sex-matched healthy controls. The findings may help clarify mucosal inflammatory pathways involved in FMF and provide insight into novel therapeutic targets.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
This study includes adult patients diagnosed with Familial Mediterranean Fever (FMF) who underwent routine endoscopic evaluation with intestinal mucosal biopsies. A control group composed of age- and sex-matched individuals without inflammatory or autoimmune diseases was also included for comparative analysis. All participants were retrospectively selected based on availability of adequate tissue samples and relevant clinical data.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: Grup 1: Group Title: FMF Patients Group/Cohort Label: FMF
Group B: Grup 2: Group Title: Healthy Controls Group/Cohort Label: Control
Trial outcomes
Primary outcomes
1
Level of IL-1 in Mucosal Biopsies (Semi-Quantitative Score)
Semi-quantitative scoring of immunohistochemical staining in mucosal biopsies; comparison between FMF and control groups
Time frame
Single time point, Day 1 (during biopsy analysis)2
Level of IL-18 in Mucosal Biopsies (Semi-Quantitative Score)
Semi-quantitative scoring of immunohistochemical staining in mucosal biopsies; comparison between FMF and control groups
Time frame
Single time point, Day 1 (during biopsy analysis)3
Caspase-1 Expression in Mucosal Biopsies (Semi-Quantitative Score)
Semi-quantitative scoring of immunohistochemical staining in mucosal biopsies; comparison between FMF and control groups
Time frame
Single time point, Day 1 (during biopsy analysis)Sponsors and contacts
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Source ClinicalTrials.gov
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