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Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT00751933
Recruitment Status : Terminated (Lack of patients compatible with the protocol´s criteria)
First Posted : September 12, 2008
Results First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: Vaccine Vivotif + Vaccine Dukoral + oats Biological: Vaccine Vivotif + Vaccine Dukoral Dietary Supplement: Oats Other: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2008
Primary Completion Date : October 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Symptom Score Improvement of 3 or More During or After 6 Months [ Time Frame: 6 months ]
    No patient completed the study, therefore we have no information to report.


Secondary Outcome Measures :
  1. Symptom Score Improvement of 2 or More During or After 6 Months [ Time Frame: 6 months ]
    No patient completed the study, therefore we have no information to report.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751933


Locations
Norway
Department of Medicine, Haukeland Universtiy Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Helse Vest
Investigators
Principal Investigator: Gunnar Nysæter, MD Department of Medicine,Haukeland University Hospital, Bergen, Norway
More Information

Responsible Party: Gunnar Nysæter, Senior Consultant, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00751933     History of Changes
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 )
First Posted: September 12, 2008    Key Record Dates
Results First Posted: April 28, 2015
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Gunnar Nysæter, Haukeland University Hospital:
Ulcerative colitis
Vaccines
Oats

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs