Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00751933
• Collaborator: Helse Vest (Other)
• Enrollment: 3
• Location: 1
• Arms: 4
• Duration (Months): 20
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Biological: Vaccine Vivotif + Vaccine Dukoral + oats; Biological: Vaccine Vivotif + Vaccine Dukoral; Dietary Supplement: Oats; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, 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.
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gunnar Nysæter, Senior Consultant, Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT00751933
• Other Study ID Numbers: 16816 NSD; 2007-002415-88 (SLV/EudraCT); 911305 (Helse Vest RHF); 82/2007 (P REK Nord); 16816 (NSD)
• First Posted: Sep 12, 2008
• Last Update Posted: Apr 28, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Gunnar Nysæter, Senior Consultant, Haukeland University Hospital: Ulcerative colitis; Vaccines; Oats
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Vaccines

Study Results

Participant Flow

Arm/Group Title	Vaccine Arm 2	Oats Supplement 3	Placebo 4	Vaccine and Oats 1
Arm/Group Description	Vaccination with Vivotif and Dukoral 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.	Dietary supplement with oats Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.	Placebo instead of vaccines No dietary supplement Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine	Vaccination with Vivotif and Dukoral + dietary supplement with oats. 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.
Period Title: Overall Study
STARTED	0	1	1	1
COMPLETED	0	0	0	0
NOT COMPLETED	0	1	1	1

Baseline Characteristics

Arm/Group Title	All Arms
Arm/Group Description	Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32
Sex: Female, Male (Count of Participants)
Female	2 66.7%
Male	1 33.3%
Region of Enrollment (participants) [Number]
Norway	3 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Arms
Arm/Group Description	No patient completed the study, therefore we have no information to report.
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Arms
Arm/Group Description	No patient completed the study, therefore we have no information to report.
Measure Participants	0

Adverse Events

Arm/Group Title	All Arms
Arm/Group Description	No adverse effects were recorded.
All Cause Mortality
	All Arms
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Arms
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	All Arms
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.