Gastroenterology

IBD Response - Recruiting

Defining microbial predictors of responsiveness to biologic therapies in Crohn’s disease and ulcerative colitis

• Study stage: Recruiting
• Sponsor: Newcastle upon Tyne Hospital
• Funder: MRC
• Therapeutic area: Gastroenterology
• Type of study: Observational

Aim: To identify and validate a predictive model for clinical response or failure to respond to biologic and JAK inhibitor (JAKi) therapies in IBD (including Crohn’s disease and ulcerative colitis), incorporating gut microbiome, clinical and human genome data.

To determine the relationship between clinical response and remission to a specific biologic or JAKi and the gut microbiome present in patients with an established diagnosis of Crohn’s disease or ulcerative colitis.

Primary outcome

Clinical response after 14 weeks.

• Population: Adults
• Design: Cohort
• Setting: Secondary Care
• Planned Sample Size: 1,325

Website:  https://www.ibd-response.co.uk

Open-IBD - Recruiting

A longitudinal multi-omics inception cohort in inflammatory bowel disease.

 Study stage: Recruiting

• Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
• Funder: Open Targets & Wellcome Sanger Institute
• Therapeutic area: Gastroenterology
• Type of study: Observational

 Objective: The objective of the Open-IBD cohort study is to recruit 1,000 IBD participants and up to 1,000 non-IBD control participants with collection of clinical metadata (including disease activity and quality of life measures and environmental exposures), and biosamples for research.

Outcome

Recruitment of 2000 patients within 4 years.

• Population: Adults
• Design: Cohort
• Setting: Secondary/Tertiary care
• Planned Sample Size: 2000

Website: https://www.open-ibd.org/