The purpose of this research study is to test the efficacy and safety of the study intervention, CurQD or placebo (non-active pill), in combination with vedolizumab prescribed as standard of care for patients with ulcerative colitis (UC)..
A prospective, 30-weeks long, treat-through, multi-center, parallel-group, double blind, placebo controlled, randomized pragmatic clinical trial to examine if there is added clinical benefit in participants with active UC receiving a combination VDZ+CurQD versus VDZ alone (with placebo). Moderately to severely active UC participants for whom VDZ was prescribed by their physician irrespective of the present trial as part of routine clinical care will be eligible. Moderate to severely active UC will be defined as a modified Mayo score of 5 to 9, with rectal bleeding score of ≥1, and with a sigmoidoscopy or colonoscopy sub-score of at least 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Capsule doses 235mg - 385mg curcumin/150mg-300mg QingDai
Matching capsules
as prescribed by participant's provider as part of routine clinical care
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of participants with clinical remission
Clinical remission is defined as a modified Mayo score (mMS) of 2 or lower with stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic sub-score 0 or 1.
Time frame: Week 14
Number of participants with a clinical response
Clinical response is defined as a decrease from baseline in the mMS of f ≥ 2 points and at least 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1.
Time frame: 14 weeks
Number of participants with corticosteroid-free remission
Corticosteroid-free remission at week 30 (end of maintenance phase of clinical trial) is defined as a mMS of 2 or lower with stool frequency sub-score of 0 or 1, rectal bleeding sub-score of 0, and an endoscopic sub-score of 0 or 1 without escalation of vedolizumab therapy (increase in dosing frequency) and without corticosteroid exposure for at last 8 weeks prior to assessment.
Time frame: Week 30
Number of participants with endoscopic improvement
Endoscopic improvement at weeks 14 and 30 defined as a centrally read endoscopy sub-score of 0 or 1 (score of 1 excludes friability). The endoscopic subscore is part of the Mayo Endoscopic Score (MES). The MES endoscopic subscore is graded: * 0\. No friability or granularity, intact vascular pattern * 1\. Mild-erythema, diminished or absent vascular markings, mild granularity * 2\. Moderate-marked erythema, absent vascular marking, granularity, friability, no ulceration * 3\. Severe-marked erythema, absent vascular markings, granularity, friability, spontaneous bleeding in the lumen, ulcerations
Time frame: Week 14 and Week 30
Number of participants with endoscopic remission
Endoscopic remission at weeks 14 and 30 defined as a centrally read endoscopy sub-score of 0. The endoscopic subscore is part of the Mayo Endoscopic Score (MES). The MES endoscopic subscore is graded: * 0\. No friability or granularity, intact vascular pattern * 1\. Mild-erythema, diminished or absent vascular markings, mild granularity * 2\. Moderate-marked erythema, absent vascular marking, granularity, friability, no ulceration * 3\. Severe-marked erythema, absent vascular markings, granularity, friability, spontaneous bleeding in the lumen, ulcerations
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Time frame: Week 14 and Week 30
Number of participants with durable clinical remission
Durable clinical remission defined as clinical remission at both week 14 and 30. Clinical response is defined as a decrease in the mMS of ≥ 2 points and at least 30% reduction, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1.
Time frame: Week 14 and Week 30