To demonstrate accumulation of *4*7-positive lymphocytes in pouchitis and changes thereof after resolution of endoscopic inflammation.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Semi-quantitative analysis of *4*7+ T-lymphocytes in ileal pouch biopsies of
chronic pouchitis patients and changes thereof after resolution of endoscopic
inflammation.
Secondary outcome
- Semi-quantitative analysis of key-players of lymphocyte trafficking in
pouchitis (e.g. MAdCAM-1, CCR9, CCR10, CCL25, CCL28, *E*7).
- Changes of lymphocyte subsets after treatment with vedolizumab.
- Vedolizumab serum levels in peripheral blood of patients treated with
vedolizumab
Background summary
Because of medically refractory disease or colorectal neoplasia development,
about 15% of ulcerative colitis (UC) patients will need a proctocolectomy with
ileal-anal pouch reconstruction (IPAA). A common complication of IPAA is
pouchitis, a nonspecific inflammation of the pouch, which occurs in about 50%
of UC patients with IPAA. The pathogenesis of pouchitis is not well understood,
but the innate and adaptive immune responses, microbiota-host interactions or
defects in intestinal epithelial cells may play a role in this. Vedolizumab, a
humanized monoclonal antibody that specifically binds to the lymphocyte
integrin *4*7 may be beneficial for the treatment of pouchitis. However,
blocking the interaction between MAdCAM-1 and *4*7 integrin on memory T and B
cells by vedolizumab, which has been shown to be beneficial in IBD, hasn*t been
studied in pouchitis yet.
Study objective
To demonstrate accumulation of *4*7-positive lymphocytes in pouchitis and
changes thereof after resolution of endoscopic inflammation.
Study design
Prospective observational study
Study burden and risks
Currently, no drugs have been approved for the treatment or prevention of
pouchitis, as well as no drugs have been proven to be beneficial in clinical
trials. This may be due to the fact that the pathophysiology is yet not clear.
The patients recruited for this study will have to undergo an endoscopy as per
routine care or study procedure, which is an invasive procedure. With this
study, we can expand the purpose of these endoscopies, by also adding a more
fundamental approach to the disease and treatment. The additive burden consists
of 6 or 12 additional biopsies (10/5 pts resp.), 1 or 2 faeces samples (10/5
pts) and one or two extra blood samples (10/5 pts).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Group 1:
- The subject has a history of ileal pouch anal anastomosis (IPAA) for Ulcerative Colitis completed at least 3 months prior to screening.
- The patient is scheduled for a surveillance or diagnostic endoscopy of the pouch
- Age from 18 years, either male or female
- Ability to give informed consent;Group 2 and 3:
- The subject has a history of ileal pouch anal anastomosis (IPAA) for Ulcerative Colitis completed at least 3 months prior to screening
- Age from 18 years, either male or female
- Ability to give informed consent
- The subject has chronic or recurrent pouchitis and may have antibiotic-dependent or antibiotic-refractory chronic pouchitis
Exclusion criteria
Group 1:
- The subject has an IPAA that is less than 3 months old.
- The subject has a history of a perforation of the intestine after endoscopy or surgery
- The subject currently has acute or chronic pouchitis, or had pouchitis in the past 3 months.
- The subject had prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab or anti-MAdCAM-1 therapy in the past 6 months.
- Inability to give informed consent
- The patient has Crohn's disease. ;Group 2 and 3:
- The subject has an IPAA that is less than 3 months old.
- The subject currently uses or has prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab or anti-MAdCAM-1 therapy in the past 6 months.
- The subject has a history of a perforation of the intestine after endoscopy or surgery
- Inability to give informed consent
- The patient has Crohn's disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60196.018.16 |
| OMON | NL-OMON24429 |