NCT00751933

Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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.
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.
DIETARY_SUPPLEMENT	Oats	One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
OTHER	Placebo	Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-10-01
• Completion: 2010-06-01
• First posted: 2008-09-12
• Last updated: 2015-04-28
• Results posted: 2015-04-28

Locations

1 site across 1 country: Norway