- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558658
Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease
September 16, 2020 updated by: Ahmed Khaled Mohammed, Assiut University
Evaluation of Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease in Assiut University Hospitals
Detection of Inflammatory Bowel Disease activity by Using new measure : Neutrophil to lymphocyte ratio
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Inflammatory bowel disease (IBD) has been a global healthcare problem with a sustained increasing incidence.
It includes two major forms, Crohn's disease (CD) and ulcerative colitis (UC), which are distinct chronic bowel-relapsing inflammatory disorders (Gharagozloo et al., 2015).
Ulcerative colitis (UC) is limitd to Mucosa and cause continuous bowel inflammation (Celikbilek et al., 2013) While Crohn disease is more complex because of its transmural inflammation and it is characterized by skip lesions, which are diseased sections of bowel next to uninvolved areas(Nishijima David L; Wisner, David H; Holmes, James F, 2016).
The prevalence of IBD is highest in the second to third decade of life with another peak in the 60-70- year-old group.(Silva
et al., 2016) Non-invasive tests, such as C reactive protein (CRP), erythrocyte sedimentation rate (ESR) and white blood cells (WBC) are therefore being increasingly recognized as important markers for initial diagnosis and disease activity detection.(Gao
et al., 2015) In recent years, the neutrophil-to-lymphocyte ratio (NLR), calculated as total neutrophil count divided by total lymphocyte count, NLR represents two different immune pathways and can be easily derived directly from a standard blood test..(Argeny et al., 2018)
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed IBD by endoscopy, clinical , biochemical correlation and histopathological biopsy
Description
Inclusion Criteria:
- patients with inflammatory bowel disease, diagnosed by endoscopy, clinical , biochemical correlation and histopathological biopsy
Exclusion Criteria:
- patients have :
- Appendicitis
- sigmoid diverticular disease
- Infectious colitis
- patients known to have cancer colon
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neutrophil to lymphocyte ratio in IBD
Time Frame: baseline
|
Determination of the prognostic value of N/L ratio in patients with IBD as a non invasive measure of disease acitivity
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Argeny S, Stift A, Bergmann M, Mittlbock M, Maschke S, Yang Y, Chitsabesan P, Riss S. Prognostic value of preoperative neutrophil-to-lymphocyte ratio in Crohn's disease. Wien Klin Wochenschr. 2018 Jun;130(11-12):398-403. doi: 10.1007/s00508-018-1322-3. Epub 2018 Feb 12.
- Celikbilek M, Dogan S, Ozbakir O, Zararsiz G, Kucuk H, Gursoy S, Yurci A, Guven K, Yucesoy M. Neutrophil-lymphocyte ratio as a predictor of disease severity in ulcerative colitis. J Clin Lab Anal. 2013 Jan;27(1):72-6. doi: 10.1002/jcla.21564. Epub 2013 Jan 4.
- Gao SQ, Huang LD, Dai RJ, Chen DD, Hu WJ, Shan YF. Neutrophil-lymphocyte ratio: a controversial marker in predicting Crohn's disease severity. Int J Clin Exp Pathol. 2015 Nov 1;8(11):14779-85. eCollection 2015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
September 16, 2020
First Posted (Actual)
September 22, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N/L ratio in IBD activity
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammatory Bowel Diseases
-
Cook Children's Health Care SystemNot yet recruitingIBD | IBD - Inflammatory Bowel Disease | IBD (Inflammatory Bowel Disease)United States
-
Ningbo Medical Center Lihuili HospitalRecruitingInflammatory Bowel Disease (IBD)China
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingIBD - Inflammatory Bowel DiseaseItaly
-
Chang Kyun LeeChonnam National University Hospital; Kyungpook National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine and other collaboratorsRecruitingInflammatory Bowel Disease (IBD)Korea, Republic of
-
Xijing HospitalNot yet recruitingInflammatory Bowel Diseases (IBD)China
-
Assiut UniversityNot yet recruitingInflammatory Bowel Disease (IBD)
-
University of British ColumbiaCompletedInflammatory Bowel Disease 11Canada
-
University of ChicagoTerminatedInflammatory Bowel Disease (IBD)United States
-
University of Texas Southwestern Medical CenterEnrolling by invitationInflammatory Bowel Disease | Inflammatory Bowel Disease (IBD)United States
-
Assiut UniversityNot yet recruitingIBD-Inflammatory Bowel Disease
Clinical Trials on Complete Blood Count
-
Assiut UniversityNot yet recruitingCritically Ill | Abdominal SepsisEgypt
-
RizLab Health, Inc.Baylor College of MedicineRecruitingInfection, Bacterial | Infection ViralUnited States
-
Sohag UniversityNot yet recruiting
-
Assiut UniversityNot yet recruitingNecrotizing Enterocolitis of Newborn
-
Siirt UniversityCompletedInfertility | Oxidative Stress | Antioxidative StressTurkey
-
Assiut UniversityCompleted
-
Assiut UniversityUnknownBlood Stream InfectionEgypt
-
Assiut UniversityUnknownNeonatal SepsisEgypt
-
Kahramanmaras Sutcu Imam UniversityCompletedThyroid Diseases | Thyroid Cancer | Thyroid Nodule | Delta Neutrophyl Index | Immature Granulocyte Count | Neutrophyl to Lymphocyte Ratio
-
Sohag UniversityNot yet recruitingJuvenile Idiopathic Arthritis