Novel Biomarkers in Inflammatory Bowel Disease

NCT03833310 | Completed

• 1 other identifier: vosrd
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The inflammatory bowel diseases represent a heterogeneous group of chronic , relapsing- inflammatory disorders of the gastrointestinal tract. Crohn's disease and ulcerative colitis are the two major clinical forms. Considerable effort has been devoted to the development of an accurate ,noninvasive biomarkers that have increased diagnostic sensitivity and specificity . Osteoprotegerin is a member of the Tumor Necrosis Factor Receptor superfamily of proteins. I is of particular importance in bone metabolism, inflammation , tumorigenesis, and other processes where cell differentiation, survival, and death are controlled. Soluble Receptor activator of nuclear factor kappa-Β ligand is known as a type II membrane protein and as a member of tumor necrosis factor superfamily . Soluble Receptor activator of nuclear factor kappa-Β ligand has been identified to affect the immune system and a binding partner of ( Osteoprotegerin ), and controls cell proliferation. NF-κB is a transcription factor that activates inhibitor of kappa B kinase in the cytosol upon being stimulated by inflammatory stimuli with subsequent signaling pathways via canonical or non-canonical lead to migration of NF-κB toward the nucleus and hence initiates the targeting gene such as pro-inflammatory cells. TFF3 is predominantly expressed in the goblet cells of the small intestine and colon . Trefoil factor 3 has a key role in mucosal defense and restitution in the gastrointestinal mucosa. It has an anti-apoptotic effect on intestinal epithelial cells. Moreover, it contributes to the stabilization and maintenance of the intestinal epithelial barrier function by simulating the recovery of tight junction proteins .

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• level of Osteoprotegerin, sRANKL, NF kappaB and TFF3 in newly diagnosed patients with inflammatory bowel disease

  measuring level of Osteoprotegerin , sRANKL, NFkappaB and TFF3 in newly diagnosed patients with inflammatory bowel disease then it will measured again after treated with corticosteroid and immune therapy or inflximab and immune therapy

  2 years

Interventions

Osteoprotegerin, sRANKL, NfKB and TFF3 markers in serum in inflammatory bowel disease DIAGNOSTIC_TEST

I will measure Osteoprotegerin , Soluble Receptor activator of nuclear factor kappa-Β ligand, Nuclear factor kappa-light-chain-enhancer of activated B cells and Trefoil factor 3 in serum of patient with inflammatory bowel disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After standardized work-up with clinical, endoscopic, histopathologicial and, when applicable, radiological evaluation, all patients will met the generally accepted international diagnostic criteria of inflamatory bowel diseaes .The healthy controls consisted of an age- and gender-matched (negative for IBD). This group did not show evidence or familial history of IBD or any other immune mediated disorders

You may qualify if:

• Newly diagnosed patients (untreated) by clinical and endoscopic examination and not received treatment .

You may not qualify if:

• patients have autoimmune diseases
• patients with cancer

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit Medical University

Asyut, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum specimen from patient with inflammatory bowel disease after diagnosis and healthy persons .second sample taking 3month after received treatment

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• nesma gamal, demonstrator

  Assiut University

  PRINCIPAL INVESTIGATOR

• ragaa salama, professor

  Assiut University

  STUDY DIRECTOR

• Amira Abdel Hamid Kamal Mohamed, Lecture

  Assiut University

  STUDY DIRECTOR

• Mohammed Ahmed Medhat, Lecture

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 7, 2019
• Study Start: November 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: April 15, 2021
• Last Updated: January 7, 2026

Record last verified: 2020-05

Locations

EG (1)