A Phase 2 interventional study of Vaccine Vivotif + Vaccine Dukoral + oats and Vaccine Vivotif + Vaccine Dukoral in Ulcerative Colitis, sponsored by Haukeland University Hospital. Terminated at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-04-28.
Sponsored by Haukeland University Hospital · Phase 2, Interventional, and Treatment
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.
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Haukeland University Hospital is the lead sponsor of 283 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Vaccination with Vivotif and Dukoral
Biological: Vaccine Vivotif + Vaccine Dukoral
Dietary supplement with oats
Dietary Supplement: Oats
Placebo instead of vaccines No dietary supplement
Other: Placebo
Vaccination with Vivotif and Dukoral + dietary supplement with oats.
Biological: Vaccine Vivotif + Vaccine Dukoral + oats
Drug page: Ty21a Typhoid Vaccine
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.
Also known as: Ty21a, Vibrio cholera O1 Ogawa, inactivated
Drug page: Ty21a Typhoid Vaccine
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.
Also known as: Ty21a, Vibrio cholera O1 Ogawa, inactivated
One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
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
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
| Milestone | Vaccine Arm 2 | Oats Supplement 3 | Placebo 4 | Vaccine and Oats 1 |
|---|---|---|---|---|
| Started | 0 | 1 | 1 | 1 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 1 |
No patient completed the study, therefore we have no information to report.
No measurements were reported for this outcome.
No patient completed the study, therefore we have no information to report.
No measurements were reported for this outcome.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Arms | — | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | All Arms |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Age, Continuous(years) | All Arms |
|---|---|
| Mean | 32 (24 to 41) |
| Sex: Female, Male(Participants) | All Arms |
|---|---|
| Female | 2 |
| Male | 1 |
| Region of Enrollment(participants) | All Arms |
|---|---|
| Norway | 3 |
The record gives a start of Oct 2008, a primary completion of Oct 2009 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2015, 5 years 6 months after primary completion.
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This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ty21a Typhoid Vaccine
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