inflammatory bowel disease (IBD) Ulcerative Colitis (CU)
Conditions
Interventions
Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two
daily doses of 3 g of the placebo, containing only the carrier material (both
produced by Winclove Probiotics).
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosed Ulcerative Colitis (left sided UC or pancolitis) - Age 18-65 (because microbiotia change at older age) - Stable disease activity (clinical remission with CRP levels
Exclusion criteria
Exclusion criteria: - History of intestinal surgery that might interfere with the outcome of the study - Diabetes Mellitus (medication dependent) - Current use of antibiotics - Current use of corticosteroids (30 days prior to the first baseline measurement). - Treatment with other medication besides mesalazine (NSAIDs, topical or systemic steroids, immunosuppressive drugs or aspirin) one week prior the first baseline measurement. - Use of other pre- and probiotics and not willing to stop these 2 weeks before the intervention period - Hypersensitivity or allergy to milk protein, soy protein and gluten - Alcohol abuse (male more than 14 servings a week, female more than 7 servings a week) - Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study - Patients foreseen to need GI surgery during the study period - Patients with a history of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter is intestinal permeability measured by several techniques: the Multi Sugar Absorption test in 24-h urine, zonulin in faeces and in serum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammation will be measured from faecal calprotectin and blood c-reactive protein (CRP) levels. Furthermore samples will be stored to measure cytokine concentrations in serum and to analyse the microbial composition of the faecal samples using the HITchip. For the disease related quality of life the irritable bowel disease questionnaire (IBD-Q) and SF-36 will be used. All parameters will be measured at three time points; t=0, t=6 and t=12 weeks. | — |
Countries
Netherlands
Outcome results
None listed