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.

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Biological: Vaccine Vivotif + Vaccine Dukoral; Dietary supplement: Oats; Other: Placebo; Biological: Vaccine Vivotif + Vaccine Dukoral + oats

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Department of Medicine, Haukeland Universtiy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2; Vaccination with Vivotif and Dukoral	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.; Other Names: Ty21a; Vibrio cholera O1 Ogawa, inactivated
Experimental: 3; Dietary supplement with oats	Dietary supplement: Oats; One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
Placebo Comparator: 4; Placebo instead of vaccines No dietary supplement	Other: Placebo; Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
Experimental: 1; Vaccination with Vivotif and Dukoral + dietary supplement with oats.	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.; Other Names: Ty21a; Vibrio cholera O1 Ogawa, inactivated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Vest
• Investigators: Principal Investigator: Gunnar Nysæter, MD, Department of Medicine,Haukeland University Hospital, Bergen, Norway

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 11, 2008
• First Posted (Estimate): September 12, 2008

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Vaccines; Ulcerative colitis; Oats
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 16816 NSD; 2007-002415-88 (SLV/EudraCT) (Other Identifier: Statens Legemiddelverk); 911305 (Helse Vest RHF) (Other Identifier: Helse Vest RHF); 82/2007 (P REK Nord) (Other Identifier: Regional Etisk Komite); 16816 (NSD) (Other Identifier: Norsk Samfunnsvitenskapelig Datatjeneste)