Clinical Outcome of Treatment of Ulcerative Colitis in Adult

NCT ID: NCT06143163

Last Updated: 2023-11-22

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

NOT_YET_RECRUITING

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-29

Study Completion Date

2026-01-29

Brief Summary

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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

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 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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Kholoud Mohamed Hassan

Dr kholoud Mohamed Hassan

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 30307487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30284911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30254405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30169204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30293556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30130840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30321913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30293913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30277409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30291026 (View on PubMed)

Other Identifiers

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Treatment of UC

Identifier Type: -

Identifier Source: org_study_id