Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06844565
Enrollment
110
Registered
2025-02-25
Start date
2021-01-01
Completion date
2023-12-31
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker, Crohn Disease, Diagnosis, Interleukin 12, Interleukin 23

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.

Interventions

PROCEDUREImmunohistochemistry procedure

Briefly, all slides will be rehydrated, and antigen retrieval will be performed using sodium citrate (pH = 6.0) in a pressure cooker (EDTA buffer, pH = 8.4). All slides will be blocked with endogenous peroxidase with 3% hydrogen peroxide and blocked non-specific protein with 2.5% bovine serum albumin in phosphate-buffered saline. If the result shows non-specific ileitis, immunohistochemical staining for IL-12 and IL-23 will be performed using sandwich enzyme-linked immunosorbent assays (ELISA).

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of IL-23 to predict Crohn's disease6 months after procedureSensitivity of IL-23 to predict Crohn's disease will be recorded.

Secondary

MeasureTime frameDescription
Sensitivity of IL-12 to predict Crohn's disease6 months after procedureSensitivity of IL-12 to predict Crohn's disease will be recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026