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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05406934
Collaborator
(none)
120
27.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Infliximab

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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Blood Platelet Indices, Platelet Aggregation and Coagulation Profile in the Activity State of Inflammatory Bowel Disease Patients on Biological Treatment
Anticipated Study Start Date :
Jun 5, 2022
Actual Primary Completion Date :
Jun 5, 2022
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
healthy group

the healthy group, not diagnosed IBD

Biological: Infliximab
obseravation with investigation

IBD patients controlled by conventional treatment

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

Biological: Infliximab
obseravation with investigation

uncontrolled IBD patients on biological's treatment

divided to uc received biological and Crohns received biolgical

Biological: Infliximab
obseravation with investigation

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Hamdy AbdelElmalak, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05406934
Other Study ID Numbers:
  • AssuitU22
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2022