E!5691 Development of the Mucosal Patch Technology as a diagnostic test for food hypersensitivity MucuMPO

This project relates to the development of a new method, the MPT (Mucosal Patch Technique), which is a diagnostic tool for identifying patients with irritable bowel syndrome (IBS) who have low-grade inflammation in their bowel. Such symptoms often cause reduced quality-of-life, and if this method can be proven through the Eurostars project, we may tailor future treatment to only those patients who are likely to respond to anti-inflammatory treatment of IBS.

One of the consortium partners (Alimenta Medical AB) has already developed and CE-marked a prototype MucoPatch catheter with the objective to use it in clinical studies. Even if the device could be commercially released, two properties make it less suitab le for this purpose: the prototype-like design finish, and the high cost of goods and manufacturing cost. Thus, a MucoPatch catheter for commercialization will be developed in this project, and contract manufacturers are being considered as partners for t his consortium or as sublicensees. Partner Diagnostics Development P & M Venge AB will develop inflammatory ELISA tests such as the neutrophil marker MPO ELISA and the eosinophil marker ECP ELISA. The tests will be fully validated and will provide requi red data to CE-mark the kits on request. Two on-going pilot studies aim to investigate the diagnostic accuracy of the MPT system and if surrogate markers could be used to define new meaningful sub-groups of the IBS population. Interim analyses of thes e pilot studies will yield information useful for fine-tuning the exact study protocol for the clinical proof-of-concept study included in the main Eurostars project proposal. Partners Karolinska University Hospital, Sahlgrenska University Hospital and Sm erud Medical Research International AS will conduct the clinical proof-of-concept (PoC) study of the MPT device and the inflammatory biomarker assays. This PoC will be obtained in the clinical setting of Irritable Bowel Syndrome (IBS).