Inflammatory Bowel DiseasesNCT05738915
Role of C-Reactive Protein /Albumin Ratio in Evaluation of Disease Activity in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- CRP/Albumin ratio in IBD
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2023to 15 Aug 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - patients with IBD which included Crohn disease and Ulcertive colitis patients above age 18 years old.
Who may be able to join
- patients with IBD which included Crohn disease and Ulcertive colitis patients above age 18 years old.
Who cannot join
- concurrent infections, liver cirrhosis, hematological diseases, heart failure, malignancies, autoimmune diseases, or congenital or acquired immunodeficiencies
Trial locations and contacts
No sites are listed yet.
About this study
Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.
Read the detailed description
Inflammatory bowel disease (IBD) is defined as a life long chronic inflammatory disease affecting the gastrointestinal tract resulting from the interaction of environmental and genetic elements, has been a global healthcare problem with a steadily increasing incide IBD is mainly composed of two different bowel-relapsing disorders, including Crohn's disease (CD) and ulcerative colitis (UC).
Early detection of the disease activity of IBD is of great significance for the treatment of this disease, which can effectively prevent complications and therefore improve prognosis as well as quality of life. In current clinical practice, commonly used noninvasive biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), are considered to be important for both early diagnosis and accurate monitoring of the disease activity in IBD patients.
The C-reactive protein/albumin ratio (CAR) is indicative of the balance between inflammation and nutritional status, making it an excellent marker for assessing disease activity in patients The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity inde (CDAI).
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- CRP/Albumin ratio in IBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP/Albumin ratio in IBDDiagnostic test
Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP/Albumin ratio in IBD
Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El Raheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738915
- Sponsor's protocol ID
- CRP/Albumin Ratio in IBD
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of C-Reactive Protein /Albumin Ratio in Evaluation of Disease Activity in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05738915
- Acronym / sponsor ID
- CRP/Albumin Ratio in IBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 22 Feb 2023 (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.
Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.
Detailed description
Inflammatory bowel disease (IBD) is defined as a life long chronic inflammatory disease affecting the gastrointestinal tract resulting from the interaction of environmental and genetic elements, has been a global healthcare problem with a steadily increasing incide IBD is mainly composed of two different bowel-relapsing disorders, including Crohn's disease (CD) and ulcerative colitis (UC).
Early detection of the disease activity of IBD is of great significance for the treatment of this disease, which can effectively prevent complications and therefore improve prognosis as well as quality of life. In current clinical practice, commonly used noninvasive biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), are considered to be important for both early diagnosis and accurate monitoring of the disease activity in IBD patients.
The C-reactive protein/albumin ratio (CAR) is indicative of the balance between inflammation and nutritional status, making it an excellent marker for assessing disease activity in patients The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity inde (CDAI).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - patients with IBD which included Crohn disease and Ulcertive colitis patients above age 18 years old.
Key inclusion criteria (1 listed)
- patients with IBD which included Crohn disease and Ulcertive colitis patients above age 18 years old.
Key exclusion criteria (1 listed)
- concurrent infections, liver cirrhosis, hematological diseases, heart failure, malignancies, autoimmune diseases, or congenital or acquired immunodeficiencies
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 |
|---|---|---|
| CRP/Albumin ratio in IBDRole of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease. | Diagnostic test | – |
Primary outcome
CRP/Albumin ratio in IBD
Time frame: Baseline
Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 1 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 22 Feb 2023. 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?
Contact Mo'men Mohamed, Master (01129395914, moemnmihamed90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP/Albumin ratio in IBD (time frame: Baseline). 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 22 Feb 2023.