7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
25 daily multi-donor FMT Capsules for 50 days
Aleris-Hamlet Hospital Copenhagen
Søborg, Denmark
Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
Simple Colitis Clinical Activity Index (SCCAI)
Time frame: Baseline, 2,8,16 and 24 weeks
Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity
Alpha diversity (Shannon-index)
Time frame: Baseline
Fecal microbiota biodiversity in fecal donors
Alpha diversity (Shannon-index)
Time frame: At donor inclusion
Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline
Alpha diversity (Shannon-index)
Time frame: 8, 16 and 24 weeks
Changes in Fecal Calprotectin in the active treatment period and follow-up period
Fecal Calprotectin
Time frame: Baseline, 8,16 and 24 weeks
Changes in patient reported quality of life: IBDQ
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Baseline, 8, 16 and 24 weeks
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