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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Diagnosis; Biomarker; Interleukin 12; Interleukin 23
• Intervention / Treatment: Procedure: Immunohistochemistry procedure

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This retrospective study will be carried out on 110 patients suspected of having Crohn's disease are present in Tanta University Hospitals in the period from January 2021 to December 2023 and the data will be collected in the duration from February 2025 to May 2025 that after approval from the institutional ethical committee.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions). Non-specific ileitis by histopathology.

Procedure: Immunohistochemistry 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of IL-23 to predict Crohn's disease	Sensitivity of IL-23 to predict Crohn's disease will be recorded.	6 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of IL-12 to predict Crohn's disease	Sensitivity of IL-12 to predict Crohn's disease will be recorded.	6 months after procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Disease; Crohn Disease
• Other Study ID Numbers: 36264PR1059/1/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No