A prospective study single centre comparative study of immunological factors in non-inflammatory bowel disease enterocutaneous fistulae

Imperial College London (UK)0 个研究点目标入组 42 人开始时间: 2010年12月22日最近更新: 2018年10月22日

适应症

试验速览

•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

•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
•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

发起方

Imperial College London (UK)