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

NCT ID: NCT04670250

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

non invasive markers

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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non invasive markers

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed Kamal Eldin Mohammed Ali

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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non invasive markers in IBD

Identifier Type: -

Identifier Source: org_study_id