Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04670250 |
| Other study ID # |
non invasive markers in IBD |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2021 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
December 2020 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
