Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

Haukeland University Hospital

Status and phase: Terminated; Phase 2

Conditions: Ulcerative Colitis

Treatments: Biological: Vaccine Vivotif + Vaccine Dukoral; Dietary Supplement: Oats; Biological: Vaccine Vivotif + Vaccine Dukoral + oats; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00751933

2007-002415-88 (SLV/EudraCT) (Other Identifier)

16816 NSD

911305 (Helse Vest RHF) (Other Identifier)

16816 (NSD) (Other Identifier)

82/2007 (P REK Nord) (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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3 participants in 4 patient groups, including a placebo group

2

Experimental group

Description:

Vaccination with Vivotif and Dukoral

Treatment:

Biological: Vaccine Vivotif + Vaccine Dukoral

3

Experimental group

Description:

Dietary supplement with oats

Treatment:

Dietary Supplement: Oats

4

Placebo Comparator group

Description:

Placebo instead of vaccines No dietary supplement

Treatment:

Other: Placebo

1

Experimental group

Description:

Vaccination with Vivotif and Dukoral + dietary supplement with oats.

Treatment:

Biological: Vaccine Vivotif + Vaccine Dukoral + oats