Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis - Full Text View

Sponsor:	Haukeland University Hospital
Collaborator:	Helse Vest
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00751933

Purpose

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	Intervention	Phase
Ulcerative Colitis	Biological: Vaccine Vivotif + Vaccine Dukoral + oats Biological: Vaccine Vivotif + Vaccine Dukoral Dietary Supplement: Oats Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Cholera Ulcerative Colitis

Drug Information available for: Cholera Vaccine

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

Symptom score improvement of 3 or more during or after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Symptom score improvement of 2 or more during or after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Professor Arnold Berstad, Institute of Medicine, University of Bergen, Norway
ClinicalTrials.gov Identifier:	NCT00751933 History of Changes
Other Study ID Numbers:	16816 NSD, 2007-002415-88 (SLV/EudraCT), 911305 (Helse Vest RHF), 82/2007 (P REK Nord), 16816 (NSD)
Study First Received:	September 11, 2008
Last Updated:	August 13, 2009
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway

Keywords provided by Haukeland University Hospital:

Ulcerative colitis
Vaccines
Oats

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012