Study of immunological factors in non-inflammatory bowel disease enterocutaneous fistulae Digestive System Enterocutaneous fistulae
Conditions
Interventions
An eligible patient will be detected at referral or seen in clinic or the ward and offered participation in this study. The study will be explained, discussed and patients encouraged to ask questions
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Non-inflammatory bowel disease enterocutaneous fistulae participants (group i): 1. Consent to the study 2. Male or female 3. Aged 18+ years 4. Single or multiple enterocutaneous fistulae for at least 3 months duration as a result of non-inflammatory bowel disease, and not responding to standard treatments 5. Enterocutaneous fistulae confirmed to be due to non-inflammatory bowel disease by radiography, endoscopy or pathological examination Inflammatory bowel disease enterocutaneous fistulae participants (group ii): 1. Consent to the study 2. Male or female 3. Aged 18+ years 4. Single or multiple enterocutaneous fistulae for at least 3 months duration as a result of inflammatory bowel disease and not responding to standard treatments 5. Enterocutaneous fistulae confirmed to be due to inflammatory bowel disease by radiography, endoscopy or pathological examination 6. Patients with stable inflammatory bowel disease Normal bowel mucosa participants (control group/group iii): 1. Consent to the study 2. Male or female 3. Aged 18+ years 4. Healthy volunteers 5. Normal endoscopic examination of the bowel 6. No prior history of inflammatory bowel disease or enterocutaneous fistulae
Exclusion criteria
Exclusion criteria: Group i and iii: 1. Current sepsis or abscess 2. Previous treatment with infliximab, investigational agents or any medication which reduces the concentration of TNF-a 3. History of Crohn's disease or ulcerative colitis Group ii: 1. Current sepsis or abscess 2. Previous treatment with infliximab, investigational agents or any medication which reduces the concentration of TNF-a 3. Patients taking steroids for inflammatory bowel disease within 1 month prior to start of the study 4. Patients with acute flare up of inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cytokine profiles in the mucosa from all three groups will be assessed using multiplex bead analysis. Cytokine blood tests machine analyser will be used to simultaneously analyse the following cytokines, chemokines and growth factors: IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-a, IFN-y, MCP-1, EGF and VEGF. Samples will be collected and stored. Once all the samples have been collected, they will be assessed using the multiplex analyser in one go. This helps to reduce bias, rather then performing the tests one by one with different quantities of reagents each time. The timepoint to perform this test will hence depend on when all the patients have been recruited. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed