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

Author:

Shapira Shiran1,Leshno Ari1,Katz Daniel2,Maharshak Nitsan3,Hevroni Gil1,Jean-David Maayan1,Kraus Sarah1,Galazan Lior1,Aroch Ilan1,Kazanov Dina1,Hallack Aharon3,Becker Stewart3,Umanski Mark3,Moshkowitz Menachem4,Dotan Iris3,Arber Nadir5

Affiliation:

1. The Integrated Cancer Prevention Center, Tel-Aviv Sourasky Medical Center, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel

2. MediGlobe Ltd, Israel

3. IBD Center, Department of Gastroenterology and Liver Diseases, Tel-Aviv Sourasky Medical Center, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel

4. The Integrated Cancer Prevention Center, Tel-Aviv Sourasky Medical Center, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel IBD Center, Department of Gastroenterology and Liver Diseases, Tel-Aviv Sourasky Medical Center, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel

5. Head, the Integrated Cancer Prevention Center, Tel-Aviv Sourasky Medical Center, 6th Weizmann St., Tel-Aviv 6423906, Israel

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-to-moderate UC.

Publisher

SAGE Publications

Subject

Gastroenterology

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