Inflammatory Bowel Disease (IBD)NCT06750315
CRP /Albumin Ratio and Neutrophil Lymphocyte Ratio in Predicting Activity in IBD Patients
An observational study of Inflammatory Bowel Disease (IBD), run by Assiut University at 2 sites in Egypt.
Trial summary
This study aimed to assess the clinical utility of the NLR (neutrophil lymphocyte ratio) and CRP Albumin ratio in predicting activity of IBD Patients in assiut university Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- How many people
- 35 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2025to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pt more than 18 years not DM not cardiac failure Not Liver failure No malignancy
Who may be able to join
- Patients more than 18 years newly diagnosed as IBD
- -
Who cannot join
- Patients Not DM Not cardiac failure Not Liver failure No malignancy
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut University
Asyut
Assiut university hospital Albumin Creatinine ratio and N/L ratio in active IBD patients, +2001090176978, Amira.16266428@med.aun.edu.eg
Assiut university hospital
Egypt, Assiut
Assiut university hospital Albumin Creatinine ratio and N/L ratio in active IBD patients, +2001090176978, Amira.16266428@med.aun.edu.eg
About this study
Official title: CRP/ Albumin Ratio and Neutrophil Lymphocyte Ratio in Predicting Activity in IBD Patients
This study aimed to assess the clinical utility of the NLR (neutrophil lymphocyte ratio) and CRP Albumin ratio in predicting activity of IBD Patients in assiut university
Read the detailed description
IBD definition term for two conditions (Crohn\'s disease and ulcerative colitis) is a chronic idiopathic inflammatory disease affecting the large intestine. It is characterized by relapsing mucosal inflammation. The aim of treatment is to induce and maintain disease remission. Assessing disease activity may help in optimizing the management of IBD patients.
The neutrophil-to-lymphocyte ratio (NLR) is a simple index that can be calculated from the results of ordinary blood tests; it is calculated from a blood sample by dividing the absolute neutrophil count by the absolute lymphocyte count . As the NLR can reflect the systemic status of inflammation or immune response.
The underlying mechanism that the NLR was a predictor of clinilcal relapse in UC patients with Mucosal healing remains poorly understood. Neutrophils induce cytotoxicity and inflammation in UC. A high NLR value may be due to high activity in UC and lowered mucosal barrier function, which may lead to the migration of neutrophils through the gut microbiota .
CRP is routinely used as a surrogate measure of intestinal inflammation and as a prognostic measure of nonresponse to medical therapy and colectomy in patients with IBD.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- CRP/ALB ratio, N/L ratio
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein /albumin ratio and neutrophil lymphocyte ratio in predicting activity in Inflammatory Bowel Disease Patients
Neutrophil lymphocyte ratio and CRP/Albumin ratio in detecting activity in IBD Patients.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Ali Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750315
- Sponsor's protocol ID
- CRP/ALB and N/L In active IBD
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Torun S, Tunc BD, Suvak B, Yildiz H, Tas A, Sayilir A, Ozderin YO, Beyazit Y, Kayacetin E. Assessment of neutrophil-lymphocyte ratio in ulcerative colitis: a promising marker in predicting disease severity. Clin Res Hepatol Gastroenterol. 2012 Oct;36(5):491-7. doi: 10.1016/j.clinre.2012.06.004. Epub 2012 Jul 27.
PubMed 22841412Nguyen AL, Brick C, Liu D, Gibson DJ, Gibson PR, Sparrow MP. Clinical utility of C-reactive protein-to-albumin ratio in the management of patients with inflammatory bowel disease. JGH Open. 2024 Apr 15;8(4):e13059. doi: 10.1002/jgh3.13059. eCollection 2024 Apr.
PubMed 38623491Demir AK, Demirtas A, Kaya SU, Tastan I, Butun I, Sagcan M, Sahin S, Tasliyurt T, Yilmaz A. The relationship between the neutrophil-lymphocyte ratio and disease activity in patients with ulcerative colitis. Kaohsiung J Med Sci. 2015 Nov;31(11):585-90. doi: 10.1016/j.kjms.2015.10.001. Epub 2015 Oct 31.
PubMed 26678939Langley BO, Guedry SE, Goldenberg JZ, Hanes DA, Beardsley JA, Ryan JJ. Inflammatory Bowel Disease and Neutrophil-Lymphocyte Ratio: A Systematic Scoping Review. J Clin Med. 2021 Sep 17;10(18):4219. doi: 10.3390/jcm10184219.
PubMed 34575330
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRP/ Albumin Ratio and Neutrophil Lymphocyte Ratio in Predicting Activity in IBD Patients
- ClinicalTrials.gov ID
- NCT06750315
- Acronym / sponsor ID
- CRP/ALB and N/L In active IBD
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- CRP/ALB ratio, N/L ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
This study aimed to assess the clinical utility of the NLR (neutrophil lymphocyte ratio) and CRP Albumin ratio in predicting activity of IBD Patients in assiut university
Detailed description
IBD definition term for two conditions (Crohn\'s disease and ulcerative colitis) is a chronic idiopathic inflammatory disease affecting the large intestine. It is characterized by relapsing mucosal inflammation. The aim of treatment is to induce and maintain disease remission. Assessing disease activity may help in optimizing the management of IBD patients.
The neutrophil-to-lymphocyte ratio (NLR) is a simple index that can be calculated from the results of ordinary blood tests; it is calculated from a blood sample by dividing the absolute neutrophil count by the absolute lymphocyte count . As the NLR can reflect the systemic status of inflammation or immune response.
The underlying mechanism that the NLR was a predictor of clinilcal relapse in UC patients with Mucosal healing remains poorly understood. Neutrophils induce cytotoxicity and inflammation in UC. A high NLR value may be due to high activity in UC and lowered mucosal barrier function, which may lead to the migration of neutrophils through the gut microbiota .
CRP is routinely used as a surrogate measure of intestinal inflammation and as a prognostic measure of nonresponse to medical therapy and colectomy in patients with IBD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pt more than 18 years not DM not cardiac failure Not Liver failure No malignancy
Key inclusion criteria (2 listed)
- Patients more than 18 years newly diagnosed as IBD
- -
Key exclusion criteria (1 listed)
- Patients Not DM Not cardiac failure Not Liver failure No malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
C-reactive protein /albumin ratio and neutrophil lymphocyte ratio in predicting activity in Inflammatory Bowel Disease Patients
Time frame: 1 years
Neutrophil lymphocyte ratio and CRP/Albumin ratio in detecting activity in IBD Patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Results publication: PubMed 22841412Torun S, Tunc BD, Suvak B, Yildiz H, Tas A, Sayilir A, Ozderin YO, Beyazit Y, Kayacetin E. Assessment of neutrophil-lymphocyte ratio in ulcerative colitis: a promising marker in predicting disease severity. Clin Res Hepatol Gastroenterol. 2012 Oct;36(5):491-7. doi: 10.1016/j.clinre.2012.06.004. Epub 2012 Jul 27.
- Results publication: PubMed 38623491Nguyen AL, Brick C, Liu D, Gibson DJ, Gibson PR, Sparrow MP. Clinical utility of C-reactive protein-to-albumin ratio in the management of patients with inflammatory bowel disease. JGH Open. 2024 Apr 15;8(4):e13059. doi: 10.1002/jgh3.13059. eCollection 2024 Apr.
- Results publication: PubMed 26678939Demir AK, Demirtas A, Kaya SU, Tastan I, Butun I, Sagcan M, Sahin S, Tasliyurt T, Yilmaz A. The relationship between the neutrophil-lymphocyte ratio and disease activity in patients with ulcerative colitis. Kaohsiung J Med Sci. 2015 Nov;31(11):585-90. doi: 10.1016/j.kjms.2015.10.001. Epub 2015 Oct 31.
- Results publication: PubMed 34575330Langley BO, Guedry SE, Goldenberg JZ, Hanes DA, Beardsley JA, Ryan JJ. Inflammatory Bowel Disease and Neutrophil-Lymphocyte Ratio: A Systematic Scoping Review. J Clin Med. 2021 Sep 17;10(18):4219. doi: 10.3390/jcm10184219.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD), run by Assiut University at 2 sites in Egypt.
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 2 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Amira Mohamed Ali Ahmed (01090176978, am3859282@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein /albumin ratio and neutrophil lymphocyte ratio in predicting activity in Inflammatory Bowel Disease Patients (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750315, which also lists 4 linked publications.
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 27 Dec 2024.