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

Not yet recruiting

• Conditions: Inflammatory Bowel Diseases; Bowel Disease
• Interventions: Biological: Infliximab

• Registration Number: NCT05406934
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2022-01-17
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-04
• Last Update Submitted: 2022-06-04
• Study Start: 2022-06-05
• Primary Completion: 2022-06-05
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
uncontrolled IBD patients on biological's treatment	Infliximab	divided to uc received biological and Crohns received biolgical
healthy group	Infliximab	the healthy group, not diagnosed IBD
IBD patients controlled by conventional treatment	Infliximab	controlled by conventional treatment and divided to UC group and Crohns group

Primary Outcome Measures

Name	Time	Method
detect of disease activity of IBD patients received biological treatment in the start and in 14 weeks after treatment compared to whose controlled by platelet indices and platelet lymphocytic ratio.	about 14 weeks after start of treatment of inflixmab	Evaluation of disease activity of IBD patients received biological treatment in the start and in 14 weeks after treatment compared to whose controlled by platelet indices and platelet lymphocytic ratio.