Study of immunological factors in non-inflammatory bowel disease enterocutaneous fistulae

Not Applicable

Completed

• Conditions: Study of immunological factors in non-inflammatory bowel disease enterocutaneous fistulae; Digestive System; Enterocutaneous fistulae

• Registration Number: ISRCTN44000447
• Lead Sponsor: Imperial College London (UK)

Brief Summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21619579 2. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28366760

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-22
• Study Completion: 2011-10-07
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cytokine profiles in the mucosa from all three groups will be assessed using multiplex <br>bead analysis. Cytokine blood tests machine analyser will be used to simultaneously <br>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.<br><br>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 Outcome Measures

Name	Time	Method
o secondary outcome measures