Clinical Outcome of Treatment of Ulcerative Colitis in Adult

Ulcerative Colitis Clinical Trial

Official title:

Clinical Outcome of Treatment of Ulcerative Colitis in Adult.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143163
• Other study ID #: Treatment of UC
• Status: Not yet recruiting
• Start date: December 29, 2024
• Est. completion date: January 29, 2026

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. characterize the response to current medical therapy in adult with ulcerative colitis . 2. Detect prognostic factors of response of biological therapy in adult with ulcerative colitis

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: January 29, 2026
• Est. primary completion date: December 29, 2025
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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:

1. patients younger than 18 years old .

2. patients known to have chronic liver disease.

3. patient known to have renal disease.

4. Patients diagnosed with cardiac disease.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

Ashton JJ, Ennis S, Beattie RM. Early-onset paediatric inflammatory bowel disease. Lancet Child Adolesc Health. 2017 Oct;1(2):147-158. doi: 10.1016/S2352-4642(17)30017-2. Epub 2017 Aug 7. — View Citation

Borman ZA, Cote-Daigneault J, Colombel JF. The risk for opportunistic infections in inflammatory bowel disease with biologics: an update. Expert Rev Gastroenterol Hepatol. 2018 Nov;12(11):1101-1108. doi: 10.1080/17474124.2018.1530983. Epub 2018 Oct 10. — View Citation

Danese S, Banerjee R, Cummings JF, Dotan I, Kotze PG, Leong RWL, Paridaens K, Peyrin-Biroulet L, Scott G, Assche GV, Wehkamp J, Yamamoto-Furusho JK. Consensus recommendations for patient-centered therapy in mild-to-moderate ulcerative colitis: the i Support Therapy-Access to Rapid Treatment (iSTART) approach. Intest Res. 2018 Oct;16(4):522-528. doi: 10.5217/ir.2018.00073. Epub 2018 Oct 16. — View Citation

Drews JD, Onwuka EA, Fisher JG, Huntington JT, Dutkiewicz M, Nogalska A, Nwomeh BC. Complications after proctocolectomy and ileal pouch-anal anastomosis in pediatric patients: A systematic review. J Pediatr Surg. 2019 Jul;54(7):1331-1339. doi: 10.1016/j.jpedsurg.2018.08.047. Epub 2018 Sep 19. — View Citation

Gisbert JP, Chaparro M. Clinical Usefulness of Proteomics in Inflammatory Bowel Disease: A Comprehensive Review. J Crohns Colitis. 2019 Mar 26;13(3):374-384. doi: 10.1093/ecco-jcc/jjy158. — View Citation

Guardiola J, Lobaton T, Cerrillo E, Ferreiro-Iglesias R, Gisbert JP, Domenech E, Chaparro M, Esteve M, Rodriguez-Moranta F; en representacion de GETECCU. Recommendations of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) on the utility of the determination of faecal calprotectin in inflammatory bowel disease. Gastroenterol Hepatol. 2018 Oct;41(8):514-529. doi: 10.1016/j.gastrohep.2018.05.029. Epub 2018 Jul 4. English, Spanish. — View Citation

Jackson B, De Cruz P. Algorithms to facilitate shared decision-making for the management of mild-to-moderate ulcerative colitis. Expert Rev Gastroenterol Hepatol. 2018 Nov;12(11):1079-1100. doi: 10.1080/17474124.2018.1530109. Epub 2018 Oct 17. — View Citation

Lee JS, Kim ES, Moon W. Chronological Review of Endoscopic Indices in Inflammatory Bowel Disease. Clin Endosc. 2019 Mar;52(2):129-136. doi: 10.5946/ce.2018.042. Epub 2018 Aug 21. — View Citation

Rodriguez-Lago I, Ferreiro-Iglesias R, Nos P, Gisbert JP; en representacion del Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU). Management of acute severe ulcerative colitis in Spain: A nationwide clinical practice survey. Gastroenterol Hepatol. 2019 Feb;42(2):90-101. doi: 10.1016/j.gastrohep.2018.09.002. Epub 2018 Oct 4. English, Spanish. — View Citation

Spiceland CM, Lodhia N. Endoscopy in inflammatory bowel disease: Role in diagnosis, management, and treatment. World J Gastroenterol. 2018 Sep 21;24(35):4014-4020. doi: 10.3748/wjg.v24.i35.4014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Characterize the response to current medical therapy in adult with Ulcerative colitis	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.	Baseline