{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T10:29:40Z","timestamp":1774261780845,"version":"3.50.1"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,7,21]],"date-time":"2023-07-21T00:00:00Z","timestamp":1689897600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"First Wave BioPharma Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,6,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Oral and rectal formulations of 5-aminosalicylic acid are the first-line therapy for mild-to-moderate, distal ulcerative colitis (UC), but such a treatment is not effective in one-third of patients. Niclosamide is a small molecule, developed and approved as an orally administered drug to treat helminthic infections, with an excellent safety profile. Preclinical work showed that niclosamide is an anti-inflammatory agent, thereby providing the rationale to explore its safety and efficacy in patients with UC. This phase 1, open-label trial was aimed at assessing the safety of niclosamide formulated as an enema in patients with mild-to-moderate, distal UC, who relapsed on maintenance therapy with oral and\/or rectal 5-aminosalicylic acid.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Seventeen patients with active UC received niclosamide enema (150 mg\/60 mL) twice a day for 6 weeks. The primary endpoint was the safety of niclosamide treatment. Secondary endpoints included clinical remission and improvements in endoscopic Mayo\/histologic scores. Endoscopic remission percentages exclude participants meeting criteria at baseline for endoscopic remission.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Niclosamide was well tolerated by all 17 patients that were enrolled and treated. No serious adverse event was registered. Fifteen mild adverse events were registered in 6 patients and considered to be unrelated to the treatment. Clinical remission was achieved in 10 (59%) of 17 patients. Improvements of endoscopic Mayo score and histologic Geboes score were seen in 7 (58%) of 12 and 7 (41.2%) of 17 patients, respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Niclosamide enema treatment is safe and well tolerated. Niclosamide improves clinical symptoms and endoscopic\/histologic signs of UC; however, appropriately designed placebo-controlled clinical trials are required to confirm efficacy.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izad125","type":"journal-article","created":{"date-parts":[[2023,7,21]],"date-time":"2023-07-21T20:34:31Z","timestamp":1689971671000},"page":"894-899","source":"Crossref","is-referenced-by-count":6,"title":["Niclosamide Enema for Active Distal Ulcerative Colitis: A Phase 1, Open-Label Study"],"prefix":"10.1093","volume":"30","author":[{"given":"Irene","family":"Marafini","sequence":"first","affiliation":[{"name":"Department of Systems Medicine, University of Rome Tor Vergata , Rome , Italy"},{"name":"Gastroenterology Unit, Policlinico Universitario Tor Vergata , Rome , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"De Cristofaro","sequence":"additional","affiliation":[{"name":"Department of Systems Medicine, 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