Saffron and teplas nanodrugs as new thepeutic approach in inflammatory bowel disease: a pilot study

Inflammatory bowel disease (IBD), such as Crohn’s Disease and Ulcerative Colitis, is a chronic, relapsing inflammatory disorder of the gastrointestinal tract resulting from a loss of homeostasis between the intestinal immune system and the gut microbiome. The efficacious treatment of IBD, which can be progressive and very debilitating, is one of the most challenging health problems for humans worldwide. New treatment options and new drugs for IBD are continually being explored. However, chemically synthesized drugs are always accompanied by adverse reactions. Therefore, in the search for new pharmacologically active substances, natural ingredients and their extracts are receiving great attention because they can effectively treat IBD. Great efforts should focus on studies aimed at identifying specific molecular pathways involved in the etiopathogenesis of the disease and with which natural molecules could interfere. Among the natural products, saffron (stigma of Crocus sativus L.) has been used for health management since ancient times because of its several pharmacological effects such as anticonvulsant, antidepressant, anti-inflammatory, antitumor, antioxidant and neuroprotective activity. In particular, saffron also showed significant efficacy in peptic ulcer and ulcerative colitis. Recently, data obtained using a multidisciplinary approach provided evidence that saffron chemical composition is critical for its efficacy in neurodegenerative diseases and a combination of components appear essential to reach the best protection and increase tissue resilience. This project proposes the development of saffron extracts and the evaluation of their efficacy as co-adjuvant treatment in IBD. Experiments will be performed using approaches from different disciplines to unambiguously define the most active compounds and their chemical characteristics. Both saffron and tepals extracts will be investigated to test the utility of the whole flower, thus assessing and eventually exploiting, the potential of the waste product generated in the production of the saffron spice. The chemical composition and biological effect of both extracts will be fully assessed. The extracts will be tested as such or in the form of liposomal formulations on intestinal cells models exposed to pro-inflammatory noxa to evaluate their efficacy on the modulation of molecular pathways involved in IBD immune cells trafficking. The inclusion of the extracts in liposomes can enhance their bioavailability and gastrointestinal absorption by oral administration protecting them in the harsh gastric environment, increasing their permeation and sustaining their release in the gastrointestinal tract. The formulation that will give the best results in vitro will be tested on patients. A multidisciplinary approach is essential to optimize the results and offer to patients a well-characterized and effective product.