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Sponsors and Collaborators: |
Haukeland University Hospital Helse Vest RHF |
Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00751933 |
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.
Condition | Intervention | Phase |
Ulcerative Colitis |
Biological: Vaccine Vivotif + Vaccine Dukoral + oats Biological: Vaccine Vivotif + Vaccine Dukoral Dietary Supplement: Oats Other: Placebo |
Phase II |
Genetics Home Reference related topics: | Crohn disease |
MedlinePlus related topics: | Ulcerative Colitis |
ChemIDplus related topics: | Sodium bicarbonate Cholera Vaccine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 36 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: Experimental
Vaccination with Vivotif and Dukoral
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Biological: Vaccine Vivotif + Vaccine Dukoral
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.
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3: Experimental
Dietary supplement with oats
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Dietary Supplement: Oats
One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
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4: Placebo Comparator
Placebo instead of vaccines No dietary supplement
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Other: Placebo
Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
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1: Experimental
Vaccination with Vivotif and Dukoral + dietary supplement with oats.
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Biological: Vaccine Vivotif + Vaccine Dukoral + oats
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. |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gunnar Nysæter, MD | +4755972183 | gunnar.nysaeter@helse-bergen.no |
Contact: Arnold Berstad, PhD | +4755972133 | arnold.berstad@helse-bergen.no |
Norway | |||||
Department of Medicine, Haukeland Universtiy Hospital | Not yet recruiting | ||||
Bergen, Norway, 5021 | |||||
Contact: Gunnar Nysæter, MD +4755972183 gunnar.nysaeter@helse-bergen.no | |||||
Contact: Arnold Berstad, PhD +4755972133 arnold.berstad@helse-bergen.no | |||||
Principal Investigator: Gunnar Nysæter, MD |
Haukeland University Hospital |
Helse Vest RHF |
Principal Investigator: | Gunnar Nysæter, MD | Department of Medicine,Haukeland University Hospital, Bergen, Norway |
Responsible Party: | Institute of Medicine, University of Bergen, Norway ( Professor Arnold Berstad ) |
Study ID Numbers: | 16816 NSD, 2007-002415-88 (SLV/EudraCT), 911305 (Helse Vest RHF), 82/2007 (P REK Nord), 16816 (NSD) |
First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751933 |
Health Authority: | Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway |
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