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The Validity of Novel Non-invasive Inflammatory Markers for Monitoring of Patients With Ulcerative Colitis

The Validity of Novel Non-invasive Inflammatory Markers for Monitoring of Patients With Ulcerative Colitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04670250
Enrollment
160
Registered
2020-12-17
Start date
2021-06-30
Completion date
2022-12-31
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin

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.

Interventions

DIAGNOSTIC_TESTnon invasive markers

non invasive markers (IL6, serum ferritin, fecal lactoferrin) used for monitoring of newly diagnosed patients with ulcerative colitis

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
The Validity of Novel Noninvasive Inflammatory Markers for Monitoring of Patients with Ulcerative Colitis.18 monthsthe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026