Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vaccine Vivotif + Vaccine Dukoral + oats; Vaccine Vivotif + Vaccine Dukoral; Oats; Placebo
Intervention description: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.
One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.; Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.; One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.; Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ulcerative colitis; Vaccines; Oats

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 an improvement or even normalisation of this balance may be achieved by the
      use of vaccines and dietary oats. The combined use of oral typhoid vaccine and
      cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats
      modifies the microbial environment inside the intestinal lumen. Or study aim is to show if
      such treatment brings symptom relief to patients with ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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