Of mice and men: A novel dietary supplement for the treatment of ulcerative colitis

Shiran Shapira, Ari Leshno, Daniel Katz, Nitsan Maharshak, Gil Hevroni, Maayan Jean-David, Sarah Kraus, Lior Galazan, Ilan Aroch, Dina Kazanov, Aharon Hallack, Stewart Becker, Mark Umanski, Menachem Moshkowitz, Iris Dotan, Nadir Arber*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Curcumin, green tea polyphenols and selenium possess anti-inflammatory and anti-oxidant properties. Individually they have demonstrated some efficacy in animal models and human subjects with inflammatory bowel disease (IBD). To evaluate the efficacy and safety of Coltect [Curcumin (500 mg), green tea (250 mg) and selenium (100 µg)] in vivo and in patients with ulcerative colitis (UC). Methods: Each component was compared to placebo in a DSS mice colitis model. The efficacy was validated in a 2,4,6-trinitrobenzenesulfonic acid (TNBS) rat colitis model. Twenty patients with mild-to-moderate UC received two Coltect tablets twice daily for 8 weeks. Enrollees underwent sigmoidoscopy at study entrance and closure, and physical and laboratory evaluation at baseline, 4 and 8 weeks. Results: Coltect showed a synergistic therapeutic effect in the DSS and TNBS models. Disease activity was significantly higher in the placebo versus the treated group (p < 0.05). Selenium was the more active component. The contribution of green tea was minor. In the TNBS model, the Wallace scores for macroscopic lesions were 4.8 ± 1.5 (treatment) and 8.2 ± 0.5 (placebo) (p = 0.01). In humans, Coltect was well tolerated and effective. Fourteen subjects (70%) improved: nine (45%) went into complete remission, four (20%) experienced marked improvement and one (5%) experienced moderate improvement at the end of the trial. Clinical activity index decreased significantly at 4 and 8 weeks (p < 0.001). Two patients had no change in their symptoms, and one withdrew after 4 weeks. Flare-up in four subjects caused three to withdraw from the study after less than 4 weeks. Endoscopic improvement was observed in 11 (69%) patients, and four patients (25%) achieved complete remission. Conclusions: Coltect may serve as a first-line or add-on therapy in patients with mild-tomoderate UC.

Original languageEnglish
JournalTherapeutic Advances in Gastroenterology
Volume11
DOIs
StatePublished - 1 Jan 2018

Keywords

  • Coltect
  • Curcumin
  • Green tea
  • Selenium
  • Ulcerative colitis

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