K51
Conditions
Interventions
Group 1: synbiotic combination product with >1 billion colony forming units of Bacillus megaterium DSM 32963, 596 mg Omega-3 lysin complex, 55 µg Selenium, oral, 2x 1 capsule/day
Intervention: 28 days
Sponsors
Evonik Operations GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: patients with - established mild/moderate ulcerative colitis (grade 2/3) in treatment with 5ASA (mesalazine) and not currently or previously treated with biologic agents or steroids - who accept to undergo the study after informed consent - if woman in childbearing age, adequate contraception in place - Concomitant treatments, such as treatment for blood pressure, osteoporosis, and iron / vitamin supplements are only permitted if the therapy is stable and will likely not be discontinued during the study.
Exclusion criteria
Exclusion criteria: - pregnancy - any concomitant chronic disease or condition requiring steroids or NSAIDs therapy - diabetes - severe disease activity - unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to day 28 fecal inflammatory marker calprotectin (day 0, day 28) and comparison to placebo Pilotstudy, further endpoints listed in secondary outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Endoscopy and histology grading (day 0, day 28) - Inflammatory Bowel Disease Questionnaire (IBDQ) (day 1, day 14, day 28) - Simple Clinical Colitis Activity Index (SCCAI) (day 1, day 14, day 28) - Inflammatory mediators in blood: CRP, IL-1beta; IL-6; IL-4; IL-23; IFa, IFy and TNF- a (day 0, day 14, day 28) - Colon biopsy (day 0, day 28) | — |
Countries
Italy
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed