Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Biological: Vaccine Vivotif + Vaccine Dukoral + oats
* Biological: Vaccine Vivotif + Vaccine Dukoral
* Dietary Supplement: Oats
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Vaccination with Vivotif and Dukoral | Biological: Vaccine Vivotif + Vaccine Dukoral<br>* 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.<br>* Other names: Vibrio cholera O1 Ogawa, inactivated;|
| Experimental: 3<br>Dietary supplement with oats | Dietary Supplement: Oats<br>* One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.<br>|
| Placebo Comparator: 4<br>Placebo instead of vaccines No dietary supplement | Other: Placebo<br>* Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine<br>|
| Experimental: 1<br>Vaccination with Vivotif and Dukoral + dietary supplement with oats. | Biological: Vaccine Vivotif + Vaccine Dukoral + oats<br>* 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.<br>* Other names: Vibrio cholera O1 Ogawa, inactivated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Score Improvement of 3 or More During or After 6 Months | No patient completed the study, therefore we have no information to report. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Score Improvement of 2 or More During or After 6 Months | No patient completed the study, therefore we have no information to report. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, Vaccines, Oats