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Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

NCT00751933 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-04-28

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Helse Vest

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Gunnar Nysæter, MD · Department of Medicine,Haukeland University Hospital, Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-10-31
Completion
2010-06-30

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00751933 on ClinicalTrials.gov