Gastroenterology

IBD Response - In set-up

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

• Study stage: Set-up
• 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