Back to resultsVaccines and Dietary Oats in the Treatment of Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Vaccine Vivotif + Vaccine Dukoral + oats
Vaccine Vivotif + Vaccine Dukoral
Oats
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Vaccines, Oats
Eligibility Criteria
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
Sites / Locations
- Department of Medicine, Haukeland Universtiy Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
2
3
4
1
Arm Description
Vaccination with Vivotif and Dukoral
Dietary supplement with oats
Placebo instead of vaccines No dietary supplement
Vaccination with Vivotif and Dukoral + dietary supplement with oats.
Outcomes
Primary Outcome Measures
Symptom Score Improvement of 3 or More During or After 6 Months
No patient completed the study, therefore we have no information to report.
Secondary Outcome Measures
Symptom Score Improvement of 2 or More During or After 6 Months
No patient completed the study, therefore we have no information to report.
Full Information
NCT ID
NCT00751933
First Posted
September 11, 2008
Last Updated
April 10, 2015
Sponsor
Haukeland University Hospital
Collaborators
Helse Vest
1. Study Identification
Unique Protocol Identification Number
NCT00751933
Brief Title
Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients compatible with the protocol´s criteria
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haukeland University Hospital
Collaborators
Helse Vest
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis, Vaccines, Oats
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
Vaccination with Vivotif and Dukoral
Arm Title
3
Arm Type
Experimental
Arm Description
Dietary supplement with oats
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo instead of vaccines No dietary supplement
Arm Title
1
Arm Type
Experimental
Arm Description
Vaccination with Vivotif and Dukoral + dietary supplement with oats.
Intervention Type
Biological
Intervention Name(s)
Vaccine Vivotif + Vaccine Dukoral + oats
Other Intervention Name(s)
Ty21a, Vibrio cholera O1 Ogawa, inactivated
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Vaccine Vivotif + Vaccine Dukoral
Other Intervention Name(s)
Ty21a, Vibrio cholera O1 Ogawa, inactivated
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oats
Intervention Description
One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
Primary Outcome Measure Information:
Title
Symptom Score Improvement of 3 or More During or After 6 Months
Description
No patient completed the study, therefore we have no information to report.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Symptom Score Improvement of 2 or More During or After 6 Months
Description
No patient completed the study, therefore we have no information to report.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Nysæter, MD
Organizational Affiliation
Department of Medicine,Haukeland University Hospital, Bergen, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Haukeland Universtiy Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis
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