Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

NCT00751933 | Terminated Phase 2 Results

• 5 other identifiers: 16816 NSD2007-002415-88 (SLV/EudraCT)911305 (Helse Vest RHF)82/2007 (P REK Nord)16816 (NSD)
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Vaccines; Oats

Outcome Measures

Primary Outcomes (1)

• Symptom Score Improvement of 3 or More During or After 6 Months

  No patient completed the study, therefore we have no information to report.

  6 months

Secondary Outcomes (1)

• Symptom Score Improvement of 2 or More During or After 6 Months

  6 months

Study Arms (4)

2

EXPERIMENTAL

Vaccination with Vivotif and Dukoral

Biological: Vaccine Vivotif + Vaccine Dukoral

3

EXPERIMENTAL

Dietary supplement with oats

Dietary Supplement: Oats

4

PLACEBO COMPARATOR

Placebo instead of vaccines No dietary supplement

Other: Placebo

1

EXPERIMENTAL

Vaccination with Vivotif and Dukoral + dietary supplement with oats.

Biological: Vaccine Vivotif + Vaccine Dukoral + oats

Interventions

Vaccine Vivotif + Vaccine Dukoral + oats BIOLOGICAL

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

1

Vaccine Vivotif + Vaccine Dukoral BIOLOGICAL

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

2

Oats DIETARY_SUPPLEMENT

One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.

3

Placebo OTHER

Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine

4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Vest: collaborator

Study Sites (1)

Department of Medicine, Haukeland Universtiy Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Ty21a typhoid vaccine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Gunnar Nysæter or Solomon Tefera or Jan Hatlebakk
• Organization: Haukeland University Hospital

jhat@helse-bergen.no

+47 55972900

Study Officials

• Gunnar Nysæter, MD

  Department of Medicine,Haukeland University Hospital, Bergen, Norway

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2010
• Last Updated: April 28, 2015
• Results First Posted: April 28, 2015

Record last verified: 2015-04

Locations

NO (1)