An observational study in IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Assiut University · Observational
Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.
Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.
Introduction: Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.
Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.
Patients and Methods:
This is a prospective cohort study will include 160 patients. The study will be aMulticenterthat will be held in different Egyptian governorates. The patient must be, firstly, confirmed to be an ulcerative colitis patient by complete physical examination, laboratory evaluation by fecal calprotectin and CRP. Also, colonoscopy will be done for all included patients and they will be classified according to the Modified Mayo Endoscopic Score (MMES). Biopsies will be taken to confirm the diagnosis with histopathological examination. Fecal lactoferrin, S ferritin, and IL6 (the investigated markers) will be conducted for patients with confirmed diagnosis with UC. . All investigations, including colonoscopy, will be done once again after 3 months to follow up the included patients. The results of all tests will be correlated to the clinical and endoscopic findings of included patients to detect a cut off values to be used during remission and activity.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 160 is above the median of 105 across 247 observational studies indexed under Colitis.
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All newly diagnosed patients with ulcerative colitis will be included in the study
Exclusion Criteria:
patients who are newly diagnosed to have ulcerative colitis who are above 18 years old,not pregnant and not known to have cancer colon
Diagnostic Test: non invasive markers
non invasive markers (IL6, serum ferritin, fecal lactoferrin) used for monitoring of newly diagnosed patients with ulcerative colitis
The Validity of Novel Noninvasive Inflammatory Markers for Monitoring of Patients with Ulcerative Colitis.
the outcome will be to replace an invasive method used frequently to evaluate patients with ulcerative colitis like colonoscoy with a non invasive safe and hopfelly accurate method like fecal
Time frame: 18 months
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Assiut University