Clinical Outcome of Treatment of Ulcerative Colitis in Adult

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06143163

Collaborator

(none)

162

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

characterize the response to current medical therapy in adult with ulcerative colitis .
Detect prognostic factors of response of biological therapy in adult with ulcerative colitis

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis

Detailed Description

Ulcerative colitis is an idiopathic inflammatory condition of the colon which results in diffuse friability and superficial erosions on the colonic wall associated with bleeding. It is the most common form of inflammatory bowel disease worldwide. It characteristically involves inflammation restricted to the mucosa and submucosa of the colon. Typically, the disease starts in the rectum and extends proximally in a continuous manner. In the United States, the disease accounts for a quarter-million provider visits annually, and medical costs directly related to the disease are estimated to exceed four billion dollars annually.Ulcerative has no cure and is a lifelong disorder with a significant impact on both physical and mental health. The specific cause of inflammatory bowel disease is not known. There seems to be a primary genetic component since the most important independent risk factor is a family history of the disease (8% to 14% of patients). A first-degree relative of a patient with ulcerative colitis has a four times higher risk of developing the disease. Although there is little evidence to support this, it has been postulated that alterations in the composition of the gut microbiota and defects in mucosal immunity could lead to ulcerative colitis. Autoimmunity may also play an important role in the etiology of ulcerative colitis.Diagnosis of ulcerative colitis is made clinically with supportive findings on endoscopy, biopsy, and by negative stool examination for infectious causes. Because colonic infection can produce clinical findings indistinguishable from idiopathic ulcerative colitis, microbiologic studies for bacterial infection and parasitic infestation should be included in the initial evaluation.Treatment choice for patients with ulcerative colitis is based on both the extent of the disease and the severity. The prognosis during the first decade after diagnosis is often generally good, and most patients go into remission. Rectal application of medical therapy, via suppository or enema, is usually appropriate for isolated distal disease (proctitis); however, a rectal application is usually used in combination with systemic therapy to help target the distal colon and therefore decrease tenesmus.Ulcerative colitis has no cure and despite treatment, many continue to have increased bouts of stool frequency. An increase in mortality is usually seen in elderly patients, those with complications like infection, shock, anemia, and those who require repeated surgical interventions. Data show that when the disease involves the muscularis propria, it can lead to bowel dysmotility, necrosis, and gangrene. A certain number of patients also develop toxic megacolon with poor outcomes. It is estimated that about 5% of patients will develop colorectal cancer over time. The risk of colon cancer is higher in patients with pancolitis and in patients whose disease started before the age of 15. Overall, the quality of life in patients with ulcerative colitis is poor.

Study Design

Study Type:

Observational

Anticipated Enrollment :

162 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Clinical Outcome of Treatment of Ulcerative Colitis in Adult.

Anticipated Study Start Date :

Dec 29, 2024

Anticipated Primary Completion Date :

Dec 29, 2025

Anticipated Study Completion Date :

Jan 29, 2026

Outcome Measures

Primary Outcome Measures

- Characterize the response to current medical therapy in adult with Ulcerative colitis [Baseline]
The clinical course of the disease Will be assessed after 3 months of treatment according to guidelines as follow clinical assessment as regard symptoms as rectal bleeding, diarrhea, abdominal pain, stool frequency guided by mayo score. laboratory assessment including: ESR,CRP,CBC,fecalcalprotectin. Endoscopic evaluation regarding the mayo score. Histopathological assessment to evaluate the stage of activity of the disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

All Patients above age of 18 years old previously diagnosed by colonscopy and biobsy with ulcerative colitis attending IBD clinic El-Raghy liver Hospital

Exclusion Criteria:

patients younger than 18 years old .
patients known to have chronic liver disease.
patient known to have renal disease.
Patients diagnosed with cardiac disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Kholoud Mohamed Hassan, Dr kholoud Mohamed Hassan, Assiut University

ClinicalTrials.gov Identifier:

NCT06143163

Other Study ID Numbers:

Treatment of UC

First Posted:

Nov 22, 2023

Last Update Posted:

Nov 22, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Nov 22, 2023