Clinical Outcome of Treatment of Ulcerative Colitis in Adult
1 other identifier
observational
162
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2023
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedStudy Start
First participant enrolled
December 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2026
CompletedNovember 22, 2023
November 1, 2023
1 year
November 5, 2023
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
- 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 1. clinical assessment as regard symptoms as rectal bleeding, diarrhea, abdominal pain, stool frequency guided by mayo score. 2. laboratory assessment including: ESR,CRP,CBC,fecalcalprotectin. 3. Endoscopic evaluation regarding the mayo score. 4. Histopathological assessment to evaluate the stage of activity of the disease.
Baseline
Eligibility Criteria
1. diagnosed by colonscopy and biobsy with ulcerative colitis . 2. must be above 18yrs.
You may qualify if:
- All Patients above age of 18 years old previously diagnosed by colonscopy and biobsy with ulcerative colitis attending IBD clinic El-Raghy liver Hospital
You may not qualify if:
- patients younger than 18 years old .
- patients known to have chronic liver disease.
- patient known to have renal disease.
- Patients diagnosed with cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (10)
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.
PMID: 30307487BACKGROUNDJackson 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.
PMID: 30284911BACKGROUNDSpiceland 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.
PMID: 30254405BACKGROUNDAshton 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.
PMID: 30169204BACKGROUNDGuardiola 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.
PMID: 30293556BACKGROUNDLee 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.
PMID: 30130840BACKGROUNDDanese 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.
PMID: 30321913BACKGROUNDRodriguez-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.
PMID: 30293913BACKGROUNDBorman 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.
PMID: 30277409BACKGROUNDDrews 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.
PMID: 30291026BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr kholoud Mohamed Hassan
Study Record Dates
First Submitted
November 5, 2023
First Posted
November 22, 2023
Study Start
December 29, 2024
Primary Completion
December 29, 2025
Study Completion
January 29, 2026
Last Updated
November 22, 2023
Record last verified: 2023-11