Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

Phase 2

Terminated

• Conditions: Ulcerative Colitis

• Registration Number: NCT00751933
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Study Start: 2008-10
• Primary Completion: 2009-10
• Study Completion: 2010-06
• Status Verified: 2015-04
• Results First Submitted: 2015-04-10
• Results First Submitted QC: 2015-04-10
• Last Update Submitted: 2015-04-10
• Results First Posted: 2015-04-28
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Symptom Score Improvement of 3 or More During or After 6 Months	6 months	No patient completed the study, therefore we have no information to report.

Secondary Outcome Measures

Name	Time	Method
Symptom Score Improvement of 2 or More During or After 6 Months	6 months	No patient completed the study, therefore we have no information to report.

Trial Locations

Locations (1)

Department of Medicine, Haukeland Universtiy Hospital; 🇳🇴 Bergen, Norway