Evaluation of Blood Platelet Indices,Platelet Aggregation in the Activity of IBD Patients on Biological Treatment

NCT ID: NCT05406934

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-05
• Study Completion Date: 2024-10-31

Brief Summary

ulcerative colitis and Crohn's disease, the two major forms of inflammatory bowel disease, are chronic, idiopathic, relapsing inflammatory conditions of the gastrointestinal tract. The mechanism is multifactorial and may result from the combined interaction of environmental, genetic, epithelial barrier defects, dysregulated immune responses, and microbial factors

Detailed Description

Histopathological examinations play a role in the diagnosis and management of UC, but they are costly and invasive. So, non-invasive inflammatory biomarkers of IBD, such as the WBCS, ESR and CRP are used in clinical practice .

Platelets play a critical role in blood hemostasis so impaired platelet activation may cause persistent mucosal inflammation. Many studies have demonstrated that patients with IBD may have increased risks of venous thrombosis. Thrombosis is a major cause of morbidity and mortality in IBD.

Platelet to lymphocyte ratio can be easily calculated from CBC can serve as useful biomarkers for predicting mucosal inflammation in UC.

Current disease management guidelines were focused on the use of anti-inflammatory agents, aminosalicylates, and corticosteroids. However, some patients are still refractory to these therapies.

Biological therapy has revolutionized the management of inflammatory bowel disease in the last few years. There available biologic medicines are infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab. Biological therapy brought a better control of inflammatory bowel diseases. Its use requires specific care before the beginning and during the treatment.

Conditions

Bowel Disease; Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

healthy group

the healthy group, not diagnosed IBD

Infliximab

Intervention Type: BIOLOGICAL

obseravation with investigation

IBD patients controlled by conventional treatment

controlled by conventional treatment and divided to UC group and Crohns group

Infliximab

Intervention Type: BIOLOGICAL

obseravation with investigation

uncontrolled IBD patients on biological's treatment

divided to uc received biological and Crohns received biolgical

Infliximab

Intervention Type: BIOLOGICAL

obseravation with investigation

Interventions

Infliximab

obseravation with investigation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. All patients diagnosed with inflammatory bowel disease ulcerative colitis or crohn's disease

2. All IBD patients received biological treatment

3. All IBD patients controlled with conventional treatment

Exclusion Criteria

1. IBS patients

2. IBD Patients with: a) another autoimmune disease like ITP and SLE B) Bleeding tendency as hemophilia or thrombophilia C) Previous thrombotic events or on anticoagulants or antiplatelet drugs D) With another comorbidity as liver cell failure, respiratory failure, renal failure and cardiac failure

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Maria Hamdy AbdelElmalak

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AssuitU22

Identifier Type: -

Identifier Source: org_study_id