Immune responses to stool of patients with inflammatory bowel diseases treated with anti-TNF therapies
Not Applicable
- Conditions
- Inflammatory bowel diseaseDigestive System
- Registration Number
- ISRCTN62674004
- Lead Sponsor
- West Hertfordshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Inflammatory bowel disease patients initiating anti-TNF therapy
Exclusion Criteria
1. Crohn’s disease without ileal or colonic involvement
2. Ulcerative proctitis
3. Pregnancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Phenotype of monocyte/macrophages and monocyte/macrophage response to faecal supernatant measured using:<br> 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.<br> 2. Where patients undergo colonoscopy prior to or within 12 months after initiating anti-TNF therapy, colonic biopsies will be taken<br>
- Secondary Outcome Measures
Name Time Method 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.