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Completed

NCT Number: NCT06844565

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.

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Key information

Conditions

Interleukin 12 Biomarker Crohn Disease Diagnosis Digestive System Diseases Disease Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Interleukin 23 Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immunohistochemistry procedure

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).

Primary outcomes

  1. Sensitivity of IL-23 to predict Crohn's disease

    Time frame: 6 months after procedure

    Sensitivity of IL-23 to predict Crohn's disease will be recorded.

Secondary outcomes

  1. Sensitivity of IL-12 to predict Crohn's disease

    Time frame: 6 months after procedure

    Sensitivity of IL-12 to predict Crohn's disease will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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