Lymhocyte homing plays a role in the pathofysiology of pouchitis and vedolizumab could be a therapeutic target.
ID
Bron
Verkorte titel
Aandoening
Pouchitis, pouch, IPAA, Ileal pouch anal anastomosis.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Semi-quantitative analysis of α4β7+ T-lymphocytes in ileal pouch biopsies of chronic pouchitis patients and changes thereof after resolution of endoscopic inflammation.
Achtergrond van het onderzoek
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 α4β7 may be beneficial for the treatment of pouchitis. However, blocking the interaction between MAdCAM-1 and α4β7 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. With this observational study, we will look into different key players of lymphocyte trafficking in pouch biopsies of patients with and without pouchitis. We will also look at changes after treatment with vedolizumab.
Doel van het onderzoek
Lymhocyte homing plays a role in the pathofysiology of pouchitis and vedolizumab could be a therapeutic target.
Onderzoeksopzet
Group 1 and 2: 1 endoscopy
Group 3: 2 subsequent endoscopies, 1 year in between
Onderzoeksproduct en/of interventie
Group 1 and 2:
Day of endoscopy (scheduled in regular care):
- PDAI questionnaire
- Fecal sample
- 9ml Heparin tube
During endoscopy:
- 6 biopsies
Group 3:
Day of endoscopy (scheduled for EARNEST trial):
- PDAI questionnaire
- Fecal sample
- 9ml Heparin tube
During endoscopy:
- 6 biopsies
Additional endoscopy after 1 year (scheduled for EARNEST trial):
Day of endoscopy:
- PDAI questionnaire
- 5ml serum tube
- 9ml Heparin tube
During endoscopy:
- 6 biopsies
Publiek
Academic Medical Center<br>
P.O. Box 22700
Cyriel Y. Ponsioen
Amsterdam 1100 DD
The Netherlands
c.y.ponsioen@amc.nl
Wetenschappelijk
Academic Medical Center<br>
P.O. Box 22700
Cyriel Y. Ponsioen
Amsterdam 1100 DD
The Netherlands
c.y.ponsioen@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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, 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, 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.
Opzet
Deelname
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Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6303 |
| NTR-old | NTR6478 |
| CCMO | NL60196.018.16 |
| OMON | NL-OMON49464 |