This study evaluates the efficacy and safety of a bilberry derived anthocyanin-rich extract in patients with ulcerative colitis. Two thirds of participants will receive the anthocyanin-rich extract, while one third will receive placebo, for 8 weeks of treatment.
For anthocyanins (ACs), a wide range of protective biological effects have been described, such as anti-oxidative, anti-carcinogenic, anti-microbial and anti-inflammatory activities. Various research groups could identify a beneficial effect of ACs in IBD and intestinal inflammation. A total of 112 subjects will be randomized. Subjects will be screened for eligibility between 0 and 28 days prior to baseline visit. At the baseline visit, subjects with moderate to severe ulcerative colitis (Mayo score ≥6) and fulfilling all inclusion/exclusion criteria will be randomized into two treatment arms (ACRE or placebo). Total duration of drug product administration will be 8 weeks (56 days) followed by a follow-up phase of 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
3g of anthocyanin-rich extract taken daily as: 3 doses of 2x 500mg. Treatment duration 56 days (8 weeks).
3g of placebo taken daily as: 3 doses of 2x 500mg. Treatment duration 56 days (8 weeks).
Universitätsspital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Clinical response at week 8
Proportion of patients with clinical response at week 8 where clinical response is defined as the reduction of total mayo score ≥ 3 points
Time frame: 8 weeks
Clinical remission at week 8
Proportion of patients with symptomatic clinical remission at week 8, where clinical remission is defined as total mayo score ≤ 2, with no individual sub-score \> 1
Time frame: 8 weeks
Rectal bleeding
Proportion fo patients with absence of rectal bleeding at week 8, defined by the mayo subscore rectal bleeding of 0
Time frame: 8 weeks
Stool frequency
Proportion of patients with normal or enhanced stool frequency at Week 8, defined by the Mayo sub score stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0)
Time frame: 8 weeks
Endoscopic remission
Proportion of patients with endoscopic remission at Week 8, defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)
Time frame: 8 weeks
Histological remission
Proportion of patients with histological remission at Week 8, defined by the Geboes Index of grade 0 or 1
Time frame: 8 weeks
Symptomatic remission
Proportion of patients with symptomatic remission at Week 4, defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), (patient reported outcome)
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Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Time frame: 4 weeks
Rectal bleeding week 4
Proportion of patients with absence of rectal bleeding at Week 4, defined by the Mayo sub score rectal bleeding of 0
Time frame: 4 weeks
Stool frequency week 4
Proportion of patients with normal or enhanced stool frequency at Week 4, defined by the Mayo sub score stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0)
Time frame: 4 weeks
Durable symptomatic remission
Proportion of patients with durable symptomatic remission, defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0) \[PRO2\] at both Week 8 and Week 12
Time frame: 8 weeks / 12 weeks
Clinical response
Proportion of patients with clinical response at Week 8, defined as clinical remission or a three point and ≥30 % decrease from Baseline, Week 0 in the sum of the Modified Mayo score, i) rectal bleeding, ii) stool frequency and iii) endoscopy score (excluding friability), iiii) physicians global assessment (PGA)
Time frame: 8 weeks
Fecal calprotectin
Mean change in fecal calprotectin at Week 1, 2, 4, and 8 compared to Baseline, Week 0.
Time frame: 8 weeks
Steroid dosage
Mean change in steroid dosage for patients in remission at Week 8 to Week 12
Time frame: 4 weeks (follow-up phase)
SIBDQ
Mean change in each of the short inflammatory bowel disease questionnaire (SIBDQ) sub domains at Week 8 compared to Baseline, Week 0 SIBDQ data will consist of 10 individual items, scores for the 4 dimensions (bowel function, emotional status, systemic symptoms and social function) and a total score. All data will be listed and data for the 4 dimensions and total score summarized by time post-dose for each dose. Week 8 changes from baseline for the 4 dimensions and total score will be plotted and summarized by dose to visually assess dose-related changes.
Time frame: 8 weeks