Safety and efficacy of sodium hyaluronate (IBD98E) in the induction of clinical and endoscopic remission in subjects with distal ulcerative colitis.
BACKGROUND
Sodium hyaluronate can contribute to the hydration and maintenance of the integrity of the intestinal mucosa. Restoration of the protective layer with sodium hyaluronate may contribute to the induction of remission of active ulcerative colitis.


METHODS
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 ≥ 4 and sigmoidoscopy score ≥ 1) 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.


RESULTS
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).


CONCLUSIONS
IBD98E seems to be safe and effective for the induction of clinical and endoscopic remission. Placebo-controlled studies are warranted.
IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy.
Gionata
G
Fiorino
IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy.
Daniela
D
Gilardi
IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy.
Patrizia
P
Naccarato
IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy.
Orsola R
OR
Sociale
IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy. Electronic address: sdanese@hotmail.com.
Silvio
S
Danese
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000287:Administration, Topical; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001379:Azathioprine / Q000627:therapeutic use; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004359:Drug Therapy, Combination; D004733:Enema / Q000379:methods*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007413:Intestinal Mucosa / Q000473:pathology; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012074:Remission Induction; D012812:Sigmoidoscopy; D016896:Treatment Outcome; D055815:Young Adult
D000276:Adjuvants, Immunologic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007166:Immunosuppressive Agents; D019804:Mesalamine; D006820:Hyaluronic Acid; D001379:Azathioprine
Inflammatory bowel disease; Mucosal healing; Remission; Sodium hyaluronate; Ulcerative colitis