Pilot study
In vitro digestion studies conducted in MyCyFAPP project have determined the “Theoretical Optimal Dose” of enzymatic supplements (TOD) for a selection of food products. Based on these results, the Consortium designed a pilot study in Cystic Fibrosis patients. Around 40 followed a previously fixed 24-hours diet. Afterwards, through the stools collection analysis, the level of fat absorption was analyzed.
The analyses in the pilot study were very satisfying as 100% of patients followed the diet. In addition, the average coefficient of fat absorption was over 90%, suggesting that the new proposed methodology derived from in vitro studies is reliable and safe and could be applied for clinical practice.
Afterwards, the clinical trial started in January 2018 and will last until October 2018. Around 200 patients from 6 European cystic fibrosis participate in this stage of the Project