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Development of a novel nutraceutical product for the adjuvant treatment of inflammatory bowel disease

To develop a novel formulation of naturally occurring anti-oxidant/ anti-inflammatory compounds for the management and adjunctive therapy of inflammatory bowel disease (ibd).

YASOO HEALTH (YASOO) is a science-based nutraceuticals SME (Small and Medium-sized Enterprise) company founded in 2002 to develop and market novel nutritional supplements and dermatological products. YASOO is applying an innovative paradigm in health and wellness by developing proprietary, research-based products based on nutrients and naturally occurring compounds that deliver clinically proven health benefits. This approach addresses a major market need and customer demand for safe and clinically effective natural compounds. The goal of this research is to develop a novel formulation of naturally occurring antioxidant/anti-inflammatory compounds for the management and adjunctive therapy of inflammatory bowel disease (IBD). A critical pathway in the pathophysiology of IBD is the production of reactive oxygen and nitrogen species that drive the expression of endothelial cell adhesion molecules (ECAMs) that result in the recruitment and extravasation of leukocytes leading to a chronic inflammatory state. This research proposal will evaluate selected lipophilic antioxidants [and their modified derivatives] in IBD related cell culture models to determine the ability of a special compound, TPGS, with emulsifier/p-glycoprotein inhibitor properties, to enhance the efficacy of the test compounds. Preliminary data produced shows synergy of the TPGS molecule with selected antioxidants in reducing the expression of MAdCAM-1 in a murine colon micro-vessel endothelial cell line. Further development will include determining the most efficacious compounds and dose using in-vitro assays and then evaluating specific formulations in an animal model of IBD. The formulation to be developed aims to reduce inflammation, relapses and complications of IBD. The inflammation inherent in IBD often results in nutrient mal-absorption and deficiency, especially with respect to fat-soluble vitamins and nutrients that help limit inflammatory responses. A special benefit of this formulation will be overcoming nutrient mal-absorption as formulation with TPGS has been shown in clinical studies by YASOO to overcome mal-absorption of lipophilic compounds in certain disease states. After determination of the optimal compounds and doses in-vivo, additional formulation work including physical and chemical stability and antimicrobial effectiveness studies will be conducted. The formulation will then be evaluated for efficacy in pilot human clinical trials. YASOO has experience in the commercialisation of natural products for disease specific conditions (Aqua-E(R) for cholestasis, AquADEKS(R) for cystic fibrosis) and has a strategic plan for commercialisation of the product if Phase I and Phase II studies prove efficacious. Keywords: inflammation, anti-oxidants, ulcerative colitis.
Acronym: 
INFLATREAT
Project ID: 
3 930
Start date: 
01-01-2007
Project Duration: 
29months
Project costs: 
280 000.00€
Technological Area: 
Pharmaceutical Products / Drugs
Market Area: 
Therapeutic services

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