In this study, the modelling of results confirmed that not only the amount of fat, but also the food characteristics–e.g. This project included an in vitro digestion study of foods under standard CF simulated gastrointestinal conditions in order to determine the theoretical optimal dose of enzymatic supplement (TOD) per food product, based on food characteristics. The main goal of the Horizon 2020 M圜yFAPP Project is to establish an evidence-based method to identify the optimal dose of enzymatic supplements in CF, which will allow for patients’ self-management of this therapy by means of a mobile app. Few investigations have considered integration of the specific food characteristics of a wide range of foods to estimate the dose of the enzymatic supplement and no trials have been performed to study this in vivo. Recent research has identified the important influence of foods’ characteristics on the process of lipolysis. Moreover, wide intra-and inter- patient ranges of the dose of enzymatic supplement (LU/g fat) in a multicentre observational study were showed.
Recently, an enormous variability in the response to doses used in PERT among patients has been confirmed, with no clear association between CFA and the dose of the enzymatic supplement. The CFA reflects the amount of fat excreted in faeces in relation to the dietary intake of fat. ĭetermination of fat in faeces and calculation of the coefficient of fat absorption (CFA) have been used as the gold standard method to assess enzymatic supplement dosage efficacy. However, to our knowledge, no successful attempt has been made up to date. Over the last decades, several studies have concluded that evidence-based guidance is needed to adjust the dose of enzymatic supplements given in PERT. However, despite PERT, fat absorption remains insufficient in most of the patients with CF, and the inaccuracy in the dosing criterion has been suggested as a possible reason for this. This enteric-coated formulation became from then onwards the standard treatment for PERT in CF. In the 80s, enteric-coated pancrelipase enzyme supplements were applied in the clinical practice for the first time, showing an improvement in faecal fat losses as compared to the conventional pancreatic enzymes. Pancreatic Enzyme Replacement Therapy (PERT) is the indicated treatment to compensate for maldigestion and malabsorption of nutrients, and aims at maintaining or achieving an adequate nutritional status.
Pancreatic insufficiency is associated with Cystic Fibrosis (CF) in up to 85–90% of the patients.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.ĭata Availability: All relevant data are within the manuscript and Supporting Information files.įunding: This work was fully funded by the European Union and the Horizon 2020 Research and Innovation Framework Programme (PHC-26-2014 call Self management of health and disease: citizen engagement and mHealth) under grant number 643806.Ĭompeting interests: The authors have declared that no competing interests exist. Received: NovemAccepted: FebruPublished: March 12, 2019Ĭopyright: © 2019 Calvo-Lerma et al. PLoS ONE 14(3):Įditor: François Blachier, National Institute for Agronomic Research, FRANCE (2019) Clinical validation of an evidence-based method to adjust Pancreatic Enzyme Replacement Therapy through a prospective interventional study in paediatric patients with Cystic Fibrosis. Citation: Calvo-Lerma J, Hulst J, Boon M, Colombo C, Masip E, Ruperto M, et al.
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