Role of IL 12 and IL 23 as Potential Biomarkers in Diagnosis of Early Crohn's Disease

Completed

• Conditions: Interleukin 12; Interleukin 23; Biomarker; Diagnosis; Crohn Disease

• Registration Number: NCT06844565
• Lead Sponsor: Tanta University

Brief Summary

This study aims to evaluate the role of Interleukin (IL)-12 and IL-23 as potential biomarkers in the diagnosis of early Crohn's disease.

Detailed Description

Crohn's disease (CD) is characterized by periods of remission and relapse, with symptoms ranging from abdominal pain and diarrhea to severe complications such as fistulas and intestinal obstruction.

Interleukins (ILs) are known clusters of cytokines that regulate the proliferation, development, and activation of immune cells. IL-12 is predominantly a pro-inflammatory cytokine secreted by antigen-presenting cells (APC) in response to sensing of microbial components by Toll-like receptors. Another member of this family, IL-23 is also produced by DCs and macrophages after toll-like receptors (TLRs) engagement.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Age from 18 to 65 years.
• Both sexes.
• Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions).
• Non-specific ileitis by histopathology.

Exclusion Criteria

• Patients with no pathological samples through colonoscopy.
• History of other significant gastrointestinal diseases (e.g., colon cancer, ischemic bowel disease).
• Immunosuppressive therapy or biologic agents at the time of study.
• Previous abdominal surgeries.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of IL-23 to predict Crohn's disease	6 months after procedure	Sensitivity of IL-23 to predict Crohn's disease will be recorded.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of IL-12 to predict Crohn's disease	6 months after procedure	Sensitivity of IL-12 to predict Crohn's disease will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt