Clinical trial NCT04670250: The Validity of Novel Non-invasive Inflammatory Markers for Monitoring of Patients With Ulcerative Colitis
Official title: The Validity of Novel Non-invasive Inflammatory Markers for Monitoring of Patients With Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newly diagnosed patients with ulcerative colitis will be included in the study

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- Patients who are newly diagnosed to be ulcerative colitis. Patients \>18 years old.

Exclusion Criteria:

* Patients who are \>18 years old. Pregnant patients . Patients with colonic malignancies.

Primary outcomes:
measure: The Validity of Novel Noninvasive Inflammatory Markers for Monitoring of Patients with Ulcerative Colitis.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: