We investigated the safety and efficacy of sodium hyaluronate enema (IBD98E) in distal active ulcerative colitis, in a prospective, uncontrolled, open-label pilot trial. Subjects with active distal ulcerative colitis (UCDAI 鈮?#xA0;4 and sigmoidoscopy score 鈮?) received IBD98E 60 mL enema once a day. Primary endpoints were safety and clinical response rate at Day 28. Secondary endpoints included clinical remission, endoscopic remission, and tolerability of IBD98E. Paired Student's t-test was performed to assess statistically significant differences in subjects between baseline and Day 28.
Twenty-one subjects were enrolled. The overall safety profile was good; no serious adverse events were recorded. At Day 28, 9 subjects (42.9%) were clinical responders, and 10 subjects (47.6%) had an endoscopic response. Eight subjects (38.1%) achieved clinical remission, and 10 subjects (47.6%) achieved endoscopic remission. The mean average UCDAI score decreased from 6.10 to 3.81 at Day 28 (p = 0.001), and average endoscopic score decreased from 1.57 to 1.10 (p = 0.004).
IBD98E seems to be safe and effective for the induction of clinical and endoscopic remission. Placebo-controlled studies are warranted.