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

Assiut University

Status: Not yet enrolling

Conditions: Bowel Disease; Inflammatory Bowel Diseases

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Other

Identifiers

NCT05406934

AssuitU22

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

healthy group

Description:

the healthy group, not diagnosed IBD

Treatment:

Biological: Infliximab

IBD patients controlled by conventional treatment

Description:

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

Treatment:

Biological: Infliximab

uncontrolled IBD patients on biological's treatment

Description:

divided to uc received biological and Crohns received biolgical

Treatment:

Biological: Infliximab