Trial Details

Recruiting
Basic Information
Clinical ID c1975
Identifier ISRCTN15535639
Trial Title Open-IBD: a longitudinal multi-omics inception cohort in inflammatory bowel disease
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Inflammatory bowel disease Digestive System
Interventions Open-IBD is a multi-centre, prospective, observational, inception cohort study of inflammatory bowel disease (comprising Crohn's disease and ulcerative colitis) with approximately seven UK sites. The overall recruitment sample will comprise of two cohorts: 1. BD cohort subjects with inflammatory bowel disease; anticipated 50:50 split between ulcerative colitis/inflammatory bowel disease unclassified (IBD-U) and Crohn disease. 2. on-IBD cohort additional subjects referred to hospital with suspected IBD where investigations do not confirm IBD. Anticipated diagnoses in this group include but are not limited to microscopic colitis, coeliac disease, infective colitis, diverticulitis, colorectal cancer and irritable bowel syndrome. Patients will be identified by the gastroenterology teams and screened against the study eligibility criteria using the patients medical records. Eligible patients will have the study explained to them by a member of the study team and be given the Participant Information Sheet for further information. Informed, written consent will be sought prior to any baseline data data collection. Participants will provide informed consent electronically, using an approach developed and used successfully for other studies. If preferred, participants can also complete informed consent and questionnaires in paper form. Some study assessments will be completed remotely, at participants' homes and some during hospital visits. Each participant will therefore be provided with access to an online database to complete questionnaires and track samples, the study database. All participants will be enrolled for approximately 48 months, with assessments done at baseline (prior to starting treatment). Once the diagnosis has been established participants w
Participant Information
Sponsor Newcastle upon Tyne Hospitals NHS Foundation Trust
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2029-07-31