Ulcerative ColitisPhase 2NCT00751933
Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis
A Phase 2 study testing Vaccine Vivotif + Vaccine Dukoral + oats, Vaccine Vivotif + Vaccine Dukoral and Oats in people with Ulcerative Colitis, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Vaccine Vivotif + Vaccine Dukoral + oats, Vaccine Vivotif + Vaccine Dukoral and Oats
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Medicine, Haukeland Universtiy Hospital
Bergen, 5021
About this study
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.
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Vaccine Vivotif + Vaccine Dukoral + oats, Vaccine Vivotif + Vaccine Dukoral, Oats, Placebo
- Keywords
- Ulcerative colitis, Vaccines, Oats
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine Vivotif + Vaccine Dukoral + oatsBiological
Also called Ty21a, Vibrio cholera O1 Ogawa, inactivated
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.
Vaccine Vivotif + Vaccine DukoralBiological
Also called Ty21a, Vibrio cholera O1 Ogawa, inactivated
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.
OatsDietary supplement
One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
PlaceboOther
Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Vaccination with Vivotif and Dukoral Receives: Biological: Vaccine Vivotif + Vaccine Dukoral |
| 3 | Experimental | Dietary supplement with oats Receives: Dietary Supplement: Oats |
| 4 | Placebo comparator | Placebo instead of vaccines No dietary supplement Receives: Other: Placebo |
| 1 | Experimental | Vaccination with Vivotif and Dukoral + dietary supplement with oats. Receives: Biological: Vaccine Vivotif + Vaccine Dukoral + oats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Score Improvement of 3 or More During or After 6 Months
No patient completed the study, therefore we have no information to report.
Measured: 6 months
Secondary outcomes (1)
Symptom Score Improvement of 2 or More During or After 6 Months
No patient completed the study, therefore we have no information to report.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionJun 2010
Why it stopped: Lack of patients compatible with the protocol´s criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest
- Responsible party
- Principal investigator, Gunnar Nysæter, Haukeland University Hospital
- Investigators
- Gunnar Nysæter, MD, Principal investigator, Department of Medicine,Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751933
- Sponsor's protocol ID
- 16816 NSD
- Other IDs
- 2007-002415-88 (SLV/EudraCT), 911305 (Helse Vest RHF), 82/2007 (P REK Nord), 16816 (NSD)
- Status last verified
- Apr 2015
- First submitted
- 11 Sep 2008
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00751933
- Acronym / sponsor ID
- 16816 NSD
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Vaccines, Oats
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients compatible with the protocol´s criteria
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Vest
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Posted 28 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Biological: Vaccine Vivotif + Vaccine DukoralVaccination with Vivotif and Dukoral |
| 3 | Experimental | Dietary Supplement: OatsDietary supplement with oats |
| 4 | Placebo comparator | Other: PlaceboPlacebo instead of vaccines No dietary supplement |
| 1 | Experimental | Biological: Vaccine Vivotif + Vaccine Dukoral + oatsVaccination with Vivotif and Dukoral + dietary supplement with oats. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine Vivotif + Vaccine Dukoral + oatsAlso: Ty21a, Vibrio cholera O1 Ogawa, inactivatedVivotif 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. | Biological | 1 |
| Vaccine Vivotif + Vaccine DukoralAlso: Ty21a, Vibrio cholera O1 Ogawa, inactivatedVivotif 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. | Biological | 2 |
| OatsOne daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months. | Dietary supplement | 3 |
| PlaceboPlacebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine | Other | 4 |
Primary outcome
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.
1 secondary outcome
Symptom Score Improvement of 2 or More During or After 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Nysæter, MD principal investigator
Department of Medicine,Haukeland University Hospital, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaccine Vivotif + Vaccine Dukoral + oats, Vaccine Vivotif + Vaccine Dukoral and Oats in people with Ulcerative Colitis, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Score Improvement of 3 or More During or After 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.