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

December 15, 2020 updated by: Ghada Mohammed Kamal Eldin Mohammed Ali, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

160

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All newly diagnosed patients with ulcerative colitis will be included in the study

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
newly diagnosed patients with ulcerative colitis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Validity of Novel Noninvasive Inflammatory Markers for Monitoring of Patients with Ulcerative Colitis.
Time Frame: 18 months
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

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)

June 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • non invasive markers in IBD

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.

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