NCT06143163

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 29, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2026

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 5, 2023

Last Update Submit

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

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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: 30307487BACKGROUND
  • 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.

    PMID: 30284911BACKGROUND
  • 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.

    PMID: 30254405BACKGROUND
  • 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.

    PMID: 30169204BACKGROUND
  • 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.

    PMID: 30293556BACKGROUND
  • 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.

    PMID: 30130840BACKGROUND
  • 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.

    PMID: 30321913BACKGROUND
  • 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.

    PMID: 30293913BACKGROUND
  • 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.

    PMID: 30277409BACKGROUND
  • 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.

    PMID: 30291026BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

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