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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00751933
Other study ID # 16816 NSD
Secondary ID 2007-002415-88 (
Status Terminated
Phase Phase 2
First received September 11, 2008
Last updated April 10, 2015
Start date October 2008
Est. completion date June 2010

Study information

Verified date April 2015
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date June 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Norway Department of Medicine, Haukeland Universtiy Hospital Bergen

Sponsors (2)

Lead Sponsor Collaborator
Haukeland University Hospital Helse Vest

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
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