Bowel DiseaseNCT05406934
Evaluation of Blood Platelet Indices,Platelet Aggregation in the Activity of IBD Patients on Biological Treatment
An observational study of Bowel Disease and Inflammatory Bowel Diseases, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Bowel Disease, Inflammatory Bowel Diseases
- What is being tested?
- Infliximab
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2022to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Evaluation of Blood Platelet Indices, Platelet Aggregation and Coagulation Profile in the Activity State of Inflammatory Bowel Disease Patients on Biological Treatment
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
Read the 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
- Being tested
- Infliximab
- Medical subject headings
- Intestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
obseravation with investigation
| Study group | Role | What they receive |
|---|---|---|
| healthy group | the healthy group, not diagnosed IBD Receives: Biological: Infliximab | |
| IBD patients controlled by conventional treatment | controlled by conventional treatment and divided to UC group and Crohns group Receives: Biological: Infliximab | |
| uncontrolled IBD patients on biological's treatment | divided to uc received biological and Crohns received biolgical Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 14 weeks after start of treatment of inflixmab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start5 Jun 2022 (estimated)
- Primary completion5 Jun 2022
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hamdy AbdelElmalak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406934
- Sponsor's protocol ID
- AssuitU22
- Status last verified
- Jun 2022
- First submitted
- 17 Jan 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Platelet Indices, Platelet Aggregation and Coagulation Profile in the Activity State of Inflammatory Bowel Disease Patients on Biological Treatment
- ClinicalTrials.gov ID
- NCT05406934
- Acronym / sponsor ID
- AssuitU22
- Conditions
- Bowel Disease, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (estimated)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy group | – | Biological: Infliximabthe healthy group, not diagnosed IBD |
| IBD patients controlled by conventional treatment | – | Biological: Infliximabcontrolled by conventional treatment and divided to UC group and Crohns group |
| uncontrolled IBD patients on biological's treatment | – | Biological: Infliximabdivided to uc received biological and Crohns received biolgical |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximabobseravation with investigation | Biological | IBD patients controlled by conventional treatment, healthy group, uncontrolled IBD patients on biological's treatment |
Primary outcome
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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Disease and Inflammatory Bowel Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: about 14 weeks after start of treatment of inflixmab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.