Status:
TERMINATED
Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Helse Vest
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypothesise that ...
Eligibility Criteria
Inclusion
- ulcerative colitis of at least 4 months duration
- disease activity index score (Walmsley) \>5 and \</=13
- patients taking no ulcerative colitis relevant medicine, or stable doses of aminosalicylates or maximum 10mg prednisolon daily the last 2 weeks before study entry. They must remain on the same dose throughout the study (6 months).
- stool examination negative for enteric pathogens, clostridium difficile toxin and parasites
Exclusion
- ulcerative colitis disease activity index \>13
- symptoms of bowel obstruction
- other serious medical condition
- use of any of the study vaccines during the last two years
- use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first vaccine dose, or planned use during study period
- pregnant or planning to become pregnant
- breastfeeding
- chronic administration of prednisolone more than 10mg per day or steroids of equivalent dose the last 2 weeks before the first vaccine dose
- treatment with anti-tumor necrosis factor within 3 months prior to the first vaccine dose
- use of other immunosuppressants or immune modifying drugs within 30 days prior to the first vaccine dose
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00751933
Start Date
October 1 2008
End Date
June 1 2010
Last Update
April 28 2015
Active Locations (1)
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1
Department of Medicine, Haukeland Universtiy Hospital
Bergen, Norway, 5021