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Clinical Trials/NCT06844565
NCT06844565CompletedNot Applicable

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

Tanta University1 site in 1 country110 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
110
Locations
1
Primary Endpoint
Sensitivity of IL-23 to predict Crohn's disease

Study Overview

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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

  • Sensitivity of IL-12 to predict Crohn's disease(6 months after procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Galal Flefel

Lecturer of Internal Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

Study Sites (1)

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