Phase
Condition
Ulcerative Colitis
Ulcers
Crohn's Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Operated with proctocolectomy and construction of an IPAA
Prior to surgery diagnosed with ulcerative colitis according to establishedclinically, radiologic, endoscopic and histological criteria.
Diagnosed with chronic pouchitis as defined above
PDAI ≥ 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3
Age >18 years
Negative stool cultures for bacterial bowel pathogens and negative stool microscopyfor parasites
Serology negative for chronic hepatitis B
Negative examination for tuberculosis (including x-ray of thorax and a interferongamma test)
Signed informed consent
Exclusion
Exclusion Criteria:
Treatment with glucocorticoids within the last 4 weeks
Diagnosed with Crohn's disease
Need of an interpreter or if patients do not understand oral or written information.
Surgical complications as anal stenosis, leak of the anastomosis, or fistula arisingfrom the pouch
Abuse of medicine, alcohol or drugs
Ongoing treatment with NSAID (non steroid anti inflammatory drug)
Pregnancy or nursing
A diverting stoma
Malignancy or other severe chronic disease or expected longevity less than one year
Patients diagnosed with immune deficiency
Ongoing infectious disease
Contraindications against treatment with tumor necrosis factor-alpha antibody, such asheart disease, former cancer disease, in vivo vaccination within the last 4 weeks
Study Design
Connect with a study center
Odense University Hospital
Odense, 5000
DenmarkSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.