Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, Vaccines, Oats
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.
Interventions
BIOLOGICALVaccine 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.
BIOLOGICALVaccine 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.
DIETARY_SUPPLEMENTOats
One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
OTHERPlacebo
Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
Sponsors
Helse Vest
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Arms Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Arms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 32 years |
| Region of Enrollment Norway | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Symptom Score Improvement of 3 or More During or After 6 Months
No patient completed the study, therefore we have no information to report.
Time frame: 6 months
Secondary
Symptom Score Improvement of 2 or More During or After 6 Months
No patient completed the study, therefore we have no information to report.
Time frame: 6 months