P560 Curcumin-QingDai combination for patients with active ulcerative colitis: A randomized double-blinded placebo-controlled trial

Abstract Background The herbal extracts Curcumin and QingDai (QD, Indigo) were previously shown to be effective in mild-moderate moderate-severe ulcerative colitis (UC), respectively. We evaluated the efficacy safety of a combination curcumin-QingDai (CurQD) patients with active UC. Methods This was two parts trial. Part 1 an open label study 4 weeks CurQD UC, defined by Simple Clinical Colitis Activity Index (SCCAI) score ≥5 modified Mayo endoscopic sub-score≥2. 2 placebo-controlled trial conducted centers Israel Greece, that randomized UC at 2:1 ratio either enteric-coated 3gr/day or identical placebo for eight weeks. co-primary outcome week 8 clinical response (reduction SCCAI ≥3 points) objective evidence (Mayo subscore improvement ≥1 50% calprotectin reduction from baseline). Responding continued curcumin alone additional as maintenance treatment. Expression Cyp1A1 rectal mucosa assessed measure aryl-hydrocarbon receptor (AhR) pathway activation. purity, indigo indirubin content confirmed LC-MS/MS. Results There 59 enrolled parts. In analysis part 1, 7/10 responded including 3/10 who achieved remission. For 2, 95 screened 42 included (48.8% biologics and/or immuno-modulators experienced, 36.6% biologics-experienced). 43% 8% patients, respectively (p=0.033). observed 85.7% versus 30.7% (p<0.001), calprotectin-reduction 46.4% 15.4% (p=0.08) 75% 20% (p=0.036), groups, overall rate adverse events comparable between groups. Among week-8 responders CurQD, treatment resulted 93%, 80% 40% maintained response, remission clinical-biomarker respectively, 16. uniquely activation AhR pathway, gauged signficantly up-regulated expression CYP1A1 mucosa, which not among receiving placebo, 5ASA biologic drugs. Conclusion this controlled trial, found inducing patients. Induction may merit further potential target