Pouchitis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Netherlands
Outcome results
None listed