Inflammatory bowel disease Digestive System
Conditions
Interventions
Blood samples, stool samples, and biopsies will be taken in addition for research purposes where patients are undergoing interventions as part of routine clinical care.
Sponsors
West Hertfordshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inflammatory bowel disease patients initiating anti-TNF therapy
Exclusion criteria
Exclusion criteria: 1. Crohn’s disease without ileal or colonic involvement 2. Ulcerative proctitis 3. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phenotype of monocyte/macrophages and monocyte/macrophage response to faecal supernatant measured using: 1. Blood and stool samples collected at baseline and at weeks 14, 30 and 52 or at the point of loss of response after initiating anti-TNF therapy. 2. Where patients undergo colonoscopy prior to or within 12 months after initiating anti-TNF therapy, colonic biopsies will be taken | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation of patients records and bloods including CRP, Albumin and haemoglobin and stool tests including faecal calprotectin will be taken at baseline and at weeks 14, 30 and 52 or at the point of loss of response after initiating anti-TNF therapy. | — |
Countries
England, United Kingdom
Outcome results
None listed