Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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.

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

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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