Evaluation of Blood Platelet Indices,Platelet Aggregation in the Activity of IBD Patients on Biological Treatment
1 other identifier
observational
120
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2022
CompletedStudy Start
First participant enrolled
June 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 7, 2022
June 1, 2022
Same day
January 17, 2022
June 4, 2022
Conditions
Outcome Measures
Primary Outcomes (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.
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.
about 14 weeks after start of treatment of inflixmab
Study Arms (3)
healthy group
the healthy group, not diagnosed IBD
IBD patients controlled by conventional treatment
controlled by conventional treatment and divided to UC group and Crohns group
uncontrolled IBD patients on biological's treatment
divided to uc received biological and Crohns received biolgical
Interventions
obseravation with investigation
Eligibility Criteria
study will include 120 persons divided to 30 healthy persons and 90 was diagnosed inflammatory bowel disease in Asyut university hospital , 60 of those patients diagnosed ulcerative colitis , 30 of them controlled on conventional treatment , 30 patients on biological treatment and 30 patients' crohn's disease , 15 of them controlled on conventional treatment and 15 patients on biological treatment
You may qualify if:
- All patients diagnosed with inflammatory bowel disease ulcerative colitis or crohn's disease
- All IBD patients received biological treatment
- All IBD patients controlled with conventional treatment
You may not qualify if:
- IBS patients
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 17, 2022
First Posted
June 7, 2022
Study Start
June 5, 2022
Primary Completion
June 5, 2022
Study Completion
October 1, 2024
Last Updated
June 7, 2022
Record last verified: 2022-06