The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2015
• Main ID: NCT02361957
• Date of registration: 15/01/2015
• Prospective Registration: No
• Primary sponsor: Wageningen University
• Public title: The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients CUPIDO
• Scientific title: The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients
• Date of first enrolment: November 2014
• Target sample size: 40
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT02361957
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Nicole De Roos, PhD
• Affiliation: Wageningen UR

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed Ulcerative Colitis (left sided UC or pancolitis)

- Age 18-65 (because microbiota change at older age)

- Stable disease activity (clinical remission with CRP levels <10mg/L and calprotectin
<100 ug/g) as measured at baseline

- Mild disease activity (P-SCCAI <5)

- Mesalazine medication as only medication for UC with a maximum intake of 2.4 g/day

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Ecologic 825

Primary Outcome(s)

Intestinal permeability measured by the Lactulose Mannitol test (L/M test) [Time Frame: 12 weeks]

Secondary Outcome(s)

Intestinal permeability measured by the Lactulose Mannitol test (L/M test) [Time Frame: 6 weeks]

fecal calprotectin levels [Time Frame: 6 and 12 weeks]

blood CRP levels [Time Frame: 6 and 12 weeks]

interferon gamma levels [Time Frame: 6 and 12 weeks]

Intestinal permeability measured by faecal zonulin levels [Time Frame: 6 and 12 weeks]

Lipopolysaccharides levels in blood [Time Frame: 6 and 12 weeks]

Quality of life (measured by IBD-Q and SF36) [Time Frame: 6 and 12 weeks]

microbiota composition [Time Frame: 6 and 12 weeks]

Secondary ID(s)

NL46674.081.13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors